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Careers at Orchidia Pharmaceutical Industries
We are committed to deliver excellence and innovation to our clients and we look for the same qualities in our people. Our HR team strives to cope with our clients' demands through building an internal community of great calibers who have the same vision and values. If you would like to be part of an environment that encourages excellence, embrace innovation and nurtures relationships, build your profile, and apply for a suitable job for you.
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Available Jobs
QA – Compliance Supervisor
Cairo
Full time
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.
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22-Apr-2024
Qualification and Calibration Specialist
Cairo
Full time
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.
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21-Apr-2024
QA – Risk and CAPA Assessor
Cairo
Full time
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.
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21-Apr-2024
R&D Stability Pharmacist
Cairo
Full time
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.
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17-Apr-2024
R&D - Methodology and Validation Pharmacist
Cairo
Full time
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.
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17-Apr-2024
IPQA Supervisor
Cairo
Full time
Supervising quality assurance in-process control personnel and preparing the quality assurance activities including scheduling of audits, and evaluation of audit results by performing the following duties personally or through subordinates. Essential Tasks: Supervise, support the in-process control activities execution Follow up effective implementation the different processes in both WH and production and assure their compliance with the relevant SOPs and batch records. Follow up the environmental conditions in different areas and the environmental monitoring execution according to the relevant SOPs. Perform and supervise all required IPC tests that is required in different manufacturing steps as per the batch records. Responsible for sampling the samples required by the quality control department as the bulk, semi-finished and finished products samples. Ensure timely completion of quality assurance procedures, manufacturing, and packaging and in- process sampling. Report non-conformance that are identified during routine operations and in process. Review procedures and processes for accuracy and completion and act accordingly. Reviewing batch records after process compilation according to Orchidia’s QMS. Recording all the deviations which occurs at all the production process and writing and /or participate in the corrective and preventive action. Participate in complaint investigation to identify the root causes of the problem and solving it. Participate in internal or external audit whenever requested and prepare the needed reports for the conducted audits. Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes or changes in products, procedures or services. Train newly hired employee properly ensuring their ability to perform all types of tasks assigned efficiently and enhancing their skills in accordance to the approved standard. Work according to GLP, GMP and GDP rules. Shall be consulted and participated in the EHS management system [ Via reporting actions / incidents those could be occurred or occurred and attend the relevant trainings] and its improvement
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04-Apr-2024
Medical Representative (Derma)
Cairo
Full time
- 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
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21-May-2023
Validation Senior Specialist
Cairo
Full time
- Assure of the conforming of the facility, utilities, equipment and machines to perform the validation activities.- Analyze all needed data and prepare reports for quality assurance supervisor.- Prepare plan for revalidation activities - Supervise qualification activities during execution.- Prepare validation plans/protocols in cooperation with concerned departments for the production processes such as:- Process validation.- Cleaning validation.- SIP validation.- Filtration validation.- Any relevant activities required by the regulatory authorities.- - Prepare VMP for the facility as per latest guideline.- Prepare all documents/SOPs needed for different validation activities.- Review all supportive documents needed during the validation processes.- Supervise the investigation team in items related to validation and qualification activities- Prepare action plan.- Participate in CAPA system.- Follow up implementation.- 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.
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28-Mar-2023
E- Commerce Specialist
Cairo
Full time
- Analyze service quality and customer satisfaction. - Develop service operations. - Foster service innovation. - Analyze new market trends, business opportunities and market segments in global and local landscape. - Analyze past performance of collections, categories and campaigns to improve marketing effectiveness and ROI. - Assess potential partnership prospects. - Define and revise order fulfillment policies and procedures. - Develop a service recovery framework. - Develop and implement roadmap for online store's functionality. - Develop, manage, and measure performance of technology vendor relationships. - Drive e-commerce sales performance. - Generate business questions requiring data-mining and analysis. - Generate ideas and strategies based upon data-driven insights and recommendations. - Implement e-commerce strategic and tactical programes. - Manage and review e-commerce operations and processes. - Manage customer retention and loyalty programs. - Manage sales, promotions, marketing and social media campaigns and programs over digital platforms. - Manage the procurement and implementation of new technologies. - Measure order fulfillment and customer satisfaction performance. - Monitor and review data mining and analytics tools.
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02-Mar-2023
Medical Rep (Nutrition)
Cairo
Full time
- 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
Apply Now