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وظائف في Orchidia Pharmaceutical Industries
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لديك 3 خطوات لتصبح واحدًا من فريق عملنا
الوظائف المتوفرة
Toll Production Specialist
القاهرة
دوام كامل
Overall Purpose of the Job: Responsible for preparing and coordinating activities of toll production and coordination with R&D department in order to processing materials or manufacturing products in plant by performing the following duties personally. Primary Tasks: Follow up production process outside Orchidia facility. Report plan and production activity in outside to management in Orchidia. Co-ordinate between different department in Orchidia & the department of toll manufacturer including supply chain, warehouse, RD, QA, Production. Assure that production is performed according to Orchidia standard. Execute plan of registration &production at all outside manufacturing. Determine all requirement to achieve required plan. Prepare operational schedules and coordinates manufacturing activities. Monitor the production processes and its conformance to regulations and identifies any deviation and trend. Ensure that plant facilities, utilities, and equipment’s are maintained well to meet production plan. Maintain batch record and relevant documents to ensure that all production steps are performed correctly, signed by production staff and QA member. Prepare plan for process validation cleaning validation and execute the validation plan in coordination with validation team. Ensure that all rules and regulation regarding GMP are followed. Document procedures used to assemble; process and test company's products. Monitor effectiveness of production process and determines any necessary changes to processes, equipment to support the production activity. Follow up machine filling rates.
تقدم الآن
09-May-2024
Sterile Production Pharmacist
القاهرة
دوام كامل
Overall Purpose of the Job: Maintain work flow by monitoring every step of the production process; setting processing variables; observing control points and equipment; monitoring personnel and resources; studying methods; developing reporting procedures and systems; facilitating corrections to malfunctions within process control points. Primary Tasks: Prepare operational schedules and coordinate manufacturing activities. Monitor the production processes and its conformance to regulations and identifies any deviation and trend. Ensure that plant facilities, utilities, equipment are maintained well to meet production plan. Maintain batch record and relevant documents to ensure that all production steps are performed correctly, signed by production staff and quality assurance members. Prepare plan for process validation and cleaning validation and execute the validation plan in coordination with validation team. Keep tracking step by step each operation during production process and recording of the required data in the log book and review it. Ensure that all rules and regulations regarding GMP are followed. Monitor safety programs to eliminate industrial accidents. Document procedures used to assemble; process and test company's products. Monitor effectiveness of production process and determines any necessary changes to processes, equipment to support the production activity. Supervise preparation, filtration and autoclaving processes. Follow up integrity testing for used filters according to authorized SOP. Follow up availability of primary packaging materials for filling machine. Follow up cleaning and fumigation of sterile area. Monitoring of RH%, temperature, and differential pressure inside sterile area. Batch record review, revise logbooks and other documents related to sterile area. Represent production department in validation team. Represent production department in internal audit team. Conduct on job training for operators about GMP regulations during cleaning and operation of filling machines. Follow up receiving of primary packaging materials for CAM and BOTTLE PACK filling machine. Follow up machine filling rates. Complete filling stage in batch record. Follow up recording in logbooks. Receive raw materials from warehouse. Complete reconciliations of capping, over printing, check weigh, labeling and packaging stages in batch record. Follow up record in capping, over printing, check weigh, labeling and packaging logbooks. Work through, follow and adhere to safety instructions and requirements in production areas. Work according to GLP, GMP and GDP rules. Shall be consulted and participated in the EHS management system and its improvement elements.
تقدم الآن
01-May-2024
Mechanical Engineering Supervisor
القاهرة
دوام كامل
Summary of the Role: Supervise and coordinate activities of workers engaged in maintenance and repair of machinery and equipment. Responsibilities & Duties: - Supervise repairs and maintains plant equipment. - Direct technicians in establishing and maintaining an effective scheduling program of all preventive maintenance checks and the routine scheduled maintenance work on the various forms of company equipment. - Originate and develop analysis information for repairing equipment by study of operating and repair manuals. Acquire failure data and prepare maintenance plans for restoring equipment to operating condition. - Investigate and evaluate cause and extent of damage of machinery and equipment. - Determine and implement equipment replacements. - Analyzes maintenance problems, make adjustments and other corrective actions to ensure the continuous and safe functioning of the facilities and equipment’s while assures that there are minimal defects to the facilities. - Provide early detection of potential maintenance problems to predict and deter breakdowns before they occur. - Supervise the improvement of plant and equipment operating efficiency by providing maintenance and engineering support to the plant operations and prepares general diagrams, charts, drawings, and supplies requirements for maintenance function. - Develop and evaluate maintenance systems and process improvements, equipment and facility design changes, controls and improvements to improve quality and safety at plant facilities. - Evaluate, review and update all preventive maintenance work procedures. - Supervise of performing data entry of all associated preventive maintenance programs and services. - Maintain record of planned and completed maintenance. - Expedite the completion of all maintenance work activity. - Ensure that maintenance manuals, operating procedures, usage instructions, etc. for all equipment and material are available in the department. - Monitor maintenance work projects with other departments to ensure specifications (general cleanliness, safety, hazardous material, facility maintenance, operational standards) are maintained. - Delegate and monitor work assignments of maintenance staff. - Collect and evaluate departmental requests for maintenance service and determines the priority level of all in-coming work requests. - Analyze and recommend the most cost-effective approach to maintenance - and repair of facilities and equipment. - Monitor safety programs to eliminate industrial accidents and follow up, maintain and ensure implementation of safety instructions and requirements in plant. - Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes or changes in products, procedures or services. - Follow up, maintain and ensure implementation of GLP, GMP and GDP rules. - Enforce subordinates' participation and implementation of the EHS management system.
تقدم الآن
30-Apr-2024
QC Analyst - Pharmacist
القاهرة
دوام كامل
Perform routine quality control testing of product samples to support plant operations, while maintaining instruments used in analysis, preparing all needed documentation and following all safety instructions needed to work in quality control labs. Responsibilities: - Carry out Quality Control tests on different types of samples according to approved methods of analysis. - Release products from testing once all criteria are met, as specified in the procedures and testing specifications. - Maintain laboratory equipment in line with preventative maintenance schedules. - Provide guidance to the quality control team on the application of the internal and external regulatory requirements. - Develop and revise laboratory procedures in accordance with current testing guidelines and good manufacturing procedures. - Participate in validation processes of manufacturing sites and equipment through analysis of process validation and cleaning validation samples. - Perform analysis using analytical instruments, maintain instruments in good condition and perform regular checks on instruments when needed. - Prepare solutions required for analysis, and able standardize volumetric solutions. - Check and investigate all potential problems that could occur during the testing process and helping solve those problems that could create OOS results. - Implement and emphasize all lab operations according to data integrity principles. - Aware of basic knowledge of handling waste and dangerous substances and perform all operations accordingly. - The quality control analyst receive the BOM of the packaging materials after being reviewed from research and development department. - The quality control analyst shall review for its destination [export country] and this to be considered in the finished product analysis and COA issuance. - Implement waste and dangerous substance management procedures. - Store dangerous substances in line with set and applicable guidelines. - Report relevant near misses, incidents, and / or accidents in line with set procedures. - Work through, follow and adhere to safety instructions and requirements in chemist labs. - Work according to GLP, GMP and GDP rules. - Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
تقدم الآن
29-Apr-2024
QA – Compliance Supervisor
القاهرة
دوام كامل
Follow up the status of all CAPAs raised from different sources such (audits, complaints, and deviations) Also coordinating, supervising, managing and Executing compliance activities related to internal and external audits. Essential Tasks: Maintain of the CAPA system and follow up all CAPAs raised from different sources such: internal/ external audits, complaints, deviations. Handle risk management process including risk identification, analysis, evaluation and risk control and identify residual risks and their evaluation. Participate in the internal audit conduction for the activities and departments assigned. Cooperate with audit team for full filling the audit system objective and company yearly objectives. Participate in the external audit assigned to (off site) for suppliers and sites of toll manufacturing and subcontractors. Follow up on compliance related tools in the QMS with relevant company departments with the scope of implementation for standards and GMP guidelines. Report audit findings and follow up whatever necessary for successful cycle completion and Reports the checklist and audit findings for the external visits (off site visit) as per auditing annual plan, then issues annual auditing activities reports and reporting the outcomes. Participate and report assigned tasks as per quality risk projects. Collect and gather data for the management review. Participate in quality agreements drafting as per relevant system SOPs. Coordinate with related departments for the system continual improvement, conduct annual review for planned actions for its effective implementation by company departments. Use lean tools and six sigma approaches and methodologies for monitoring and opportunity identification for process improvement. Participate in opportunities identification as per Orchidia licensed standards and report them, perform and report the progress status in the annual reviews. Coordinate with CE team to implement project activities and, primarily, handle all reporting, logistical coordination, operational work, and provides assistance in day to day program activities Participate in following up technical file preparations according to MDD 93/42/EEC and the new MDR regulation 2017/745 and EC regulatory requirements. Perform periodic review for GMP of WHO / MHRA / FDA guidelines updates and legal regulations as requested by the department manager. Work through, follow and adhere to safety instructions and requirements. Work according to GLP, GMP and GDP rules. Shall be consulted and participated in the EHS management system and its improvement elements.
تقدم الآن
22-Apr-2024
Qualification and Calibration Specialist
القاهرة
دوام كامل
Responsible for the conducts of the validation plan and processes for facilities, laboratory equipment, utility systems and process equipment, writes reports that reflect the validation was performed. Essential Tasks: Issue and maintain validation master plan and calibration plan. Write validation protocols and reports. Perform validation activities described in validation protocols including thermal studies, equipment and utilities validation. Responsible for clean room qualification activities for classified areas and LAF units Maintain an up to date knowledge of validation requirements, practices and procedures. Work with validation and metrology contractors when required. Interact with manufacturing sciences and facilities / engineering departments to facilitate protocol execution as necessary. Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan. Write validation site specific and multi-site procedures. Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval. Read P and ID, Isometric and "as built" drawings. Communicate effectively with supervisor and other department's workload, priorities, and issues to maintain validation schedule. Set validation specifications for purchasing capital equipment. Perform IQ/OQ on large automated systems. Monitor safety programs to eliminate industrial accidents and follow up, maintain and ensure implementation of safety instructions and requirements in plant. Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes or changes in products, procedures or services. Follow up, maintain and ensure implementation of GLP, GMP and GDP rules.
تقدم الآن
21-Apr-2024
QA – Risk and CAPA Assessor
القاهرة
دوام كامل
Follow up the status of all CAPAs raised from different sources such (audits, complaints, and deviations) Also coordinating, supervising, managing and Executing compliance activities related to internal and external audits. Essential Tasks: Maintain of the CAPA system and follow up all CAPAs raised from different sources such: internal/ external audits, complaints, deviations. Handle risk management process including risk identification, analysis, evaluation and risk control and identify residual risks and their evaluation. Participate in the internal audit conduction for the activities and departments assigned. Cooperate with audit team for full filling the audit system objective and company yearly objectives. Participate in the external audit assigned to (off site) for suppliers and sites of toll manufacturing and subcontractors. Follow up on compliance related tools in the QMS with relevant company departments with the scope of implementation for standards and GMP guidelines. Report audit findings and follow up whatever necessary for successful cycle completion and Reports the checklist and audit findings for the external visits (off site visit) as per auditing annual plan, then issues annual auditing activities reports and reporting the outcomes. Participate and report assigned tasks as per quality risk projects. Collect and gather data for the management review. Participate in quality agreements drafting as per relevant system SOPs. Coordinate with related departments for the system continual improvement, conduct annual review for planned actions for its effective implementation by company departments. Use lean tools and six sigma approaches and methodologies for monitoring and opportunity identification for process improvement. Participate in opportunities identification as per Orchidia licensed standards and report them, perform and report the progress status in the annual reviews. Coordinate with CE team to implement project activities and, primarily, handle all reporting, logistical coordination, operational work, and provides assistance in day to day program activities Participate in following up technical file preparations according to MDD 93/42/EEC and the new MDR regulation 2017/745 and EC regulatory requirements. Perform periodic review for GMP of WHO / MHRA / FDA guidelines updates and legal regulations as requested by the department manager. Work through, follow and adhere to safety instructions and requirements. Work according to GLP, GMP and GDP rules. Shall be consulted and participated in the EHS management system and its improvement elements.
تقدم الآن
21-Apr-2024
R&D Stability Pharmacist
القاهرة
دوام كامل
Executing analytical tests for all types of stability studies and stability plans, ensuring conformity to specifications till end of shelf life of the product following policies, standards and procedures and documenting analysis final results to stability files provided to local and foreign authorities. Participate in translating business goals into research and development objectives, plans, and deliverables. Correlate the results of the performed trials and experiments and recommend any updates in procedures of stability so that optimal parameters can be achieved. Report, document and summarize the results of experimental trials and other data into a format that allow easy review by superiors. Follow up and control work flow to achieve objectives of stability with subordinates. Participate in Preparation of new products stability files to be registered and launched onto the market in accordance with local regulatory requirements and requirements of export. Execute plan of stability studies covering research and development trials, first three batches, process validation, and change or add supplier, change composition, ongoing and in-use stability study covering for all products. Monitor of stability temperature and humidity and ensure of archiving them. Prepare protocol for each stability studies containing summarized data and results. Send stability samples for micro analysis (sterility or preservative effectiveness test) for long accelerated and in use. Analyze of the new product under stability condition must meet the product specification especially impurities. Send and follow up stability samples for external analysis e.g. eye irritation, particulate matter. Create product files and necessary paperwork. Create SOPs related to stability system and covering research and development activities. Update SOPs related to stability system and covering research and development activities. Report problems relating to products in stability chambers to research and development manager immediately. Maintain and enhance capacity of stability chambers to cover different dosage form. Work through, follow and adhere to safety instructions and requirements in research and development labs. Work according to GLP, GMP and GDP rules. Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
تقدم الآن
17-Apr-2024
R&D - Methodology and Validation Pharmacist
القاهرة
دوام كامل
Overall Purpose of the Job Performing analysis activities testing of research and development, solving any problems encountered in all the developed methods of analysis, developing method of analysis and specifications for finished products, searching for methods of analysis of new products in different pharmacopeias and references. Essential Tasks: Participate in translating business goals into research and development objectives, plans, and deliverables. Correlate the results of the performed trials and experiments and recommend changes in method of analysis and procedures so that optimal parameters can be achieved. Report, document and summarize the results of experimental trials and other data into a format that allow easy review by superiors. Follow up work flow to achieve objectives of validation with subordinates. Develop methods for analysis of new drug products through literature, survey and methodological techniques. Validate analytical methods to ensure its suitability for its intended use. Ensure of transferring method with all procedures and precautions from research and development to quality control and solve any problems appear during analysis. Prepare validation files that are submitted to the registration department for local and export and cover all requirements. Reply to deficiency letters from the regulatory authorities. Review professional journals, scientific papers and updated pharmacopeia to keep abreast of changes in processing methods and legal and regulatory affairs which could impact company’s products or processes. Perform methodology and method validation of trial batches prepared in research and development laboratory. Participate in methodology meeting with quality control to discuss all OOS or any deviation in analysis of products. Prepare and maintain SOPs related to work done in the research and development department and all documents related to methodology and analytical method validation. Update specifications of finished products on ERP and research and development software. Handle and control of reference and working standards used in analysis. Update method of analysis to comply with export requirement (ECTD form). Update method of analysis to match with new technique of analysis and implementation of impurity. Participate in cleaning committee and prepare method cover they needs to apply cleaning validation. Work through, follow and adhere to safety instructions and requirements in research and development labs. Work according to GLP, GMP and GDP rules. Participate in the EHS activities. Via reporting actions / incidents those could occur or occurred and attend the relevant trainings.
تقدم الآن
17-Apr-2024
Medical Representative (Derma)
القاهرة
دوام كامل
- Responsible for the continued growth of the company by assuring that the actual sales of the line and individual products in his/her territory reach or exceed forecasted levels.- Prepares a daily, weekly and monthly schedule and develops plans for efficient operation of his/her territory.- Maintains a comprehensive and classified list of physicians, hospitals and Para- medical contacts and on a continuing basis updates “Customer Data” and enters the essentials of all interviews for future guidance. He/she effectively uses this recall system during physician interviews also use it to plans each physician, hospital and pharmacy call in advance.- Carefully assesses the potential of each hospital in his/her territory - On a continuing basis and according to the territory plan, promotes the line products to distributors’ sales staff also, monitor and inform the company about the sales and stock of different distributors in his/her territory.- On continuous basis monitor and inform the company about medicine tenders and bids launched in his/her territory. Also establish meaningful relationships with the different personnel in the technical and commercial committees of these tenders and bids.- During his/her physician contacts he/she projects a high-quality image of himself /herself and Orchidia.- Accomplishes productive sales calls by matching the sales presentation to the individual need.- Assures a “fair balance” in the detailing effort- advises the physician as to the contra-indications, precautions, side effects, accompanying usage of his/her products.- Keeps a watchful eye on different sales and marketing activities being conducted by competitors in his/her territory and keeps managers informed about such activities.- Professionally manage and coordinate the activities related to the customer service in his/her area including reply to customer requests, quotations requests, invitations, entertainments, shipping of orders in time, invoices collection or any other customer service activities.- Establishes meaningful relationships with health ministries, health authorities and distributors involved in his/her territory.- Sends different types of reports requested by his/her managers. He/she shall ensure that such reports are accurate and sent on time.- Constantly reviews his/her territory coverage program in terms of increased and more productive coverage.- Maintains all company property in good condition and does not tell any company information to an outside source
تقدم الآن