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Job Description
- Propose and control Function related budget, annual plans, operational tactics, related Function development and corrective measures if necessary.
- Establish system for revision of batch manufacturing, packaging and testing documentation which ensure their completeness, correctness and fulfillment of all necessary checks and that all planned changes or deviations have been documented and assessed before any product released for sale.
- Ensure that additional sampling, testing and inspection has been carried out or initiated appropriately to cover planned changes and deviations.
- Ensure completeness of all documents of batch file before FP batch release.
- Delegate of qualified person to judge compliance of FP batches with regulatory specifications of targeted market and EEPI internal standards and decide accordingly whether batches to be released or rejected.
- Maintain and improve the procedure of annual Product Quality Reviews (APQR) preparation and follow-up implementation of annual product quality reviews (APQR) generated Corrective/Preventive action.
- Maintain an adequate system for batch record archiving that keeps records security, safety traceability and quick access.
- Review and approve semi-finished disposal list to ensure that reject percentage is within acceptable limit and in case of deviation.
- React and handle the related quality problems aligning with Quality Assurance Manager.
- Propose to Quality Assurance Manager any forecast and operational needs and provide periodical reports with appropriate analysis regarding all validation updates to ensure effective and accurate updated records.
- Fulfill other related tasks as asked by management and as arising from the business.
- Review the registered regularity file as per registered in the market destination.
- Check that all the data of compliance with registered file are completed to approve the formula recipe of semi-finished and finished products.
- Deliver the required on the job training for all employees in the function to keep them qualified for doing their jobs properly.
Job Requirements
- B.Sc. Degree in Science.
- 10+ Years of Experience in Mid-Managerial level preferred Pharmaceutical Industry or FMCG.
