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Job Description
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
Skills
Bachelor’s degree in pharmaceutical sciences or sciences.
From 5 to 8 years of experience in pharmaceutical industry and operations.
Understanding of methodologies and best quality assurance practices.
Knowledge of documentation reviews and requirements analysis.
Ability to troubleshooting and resolving complex issues effectively.
Ability to work well through others and demonstrated leadership skills.
Ability to meet workloads and project deadlines.
Excellent English, verbal / written communication.
Excellent computer skills.
Education
Pharmaceutical Science or Science