About the Job
Job Purpose
Follow up adherence to OQ system and GMP in production areas, check batch-related documentation, and provide reports about quality performance against approved standards.
Key Responsibilities
- Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQG’s, GQMP’s and FPG’s. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
- Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
- Follow up application of OQ measures in production areas and check compliance of in-process testing.
- Ensure application of OQ measures during validation batches and planned changes.
- Monitor calibration of production equipment and IPC testing instruments.
- Review batch related documentation for completeness, correctness and compliance to approved standards.
- Report any observed incidents during routine production and follow up its correction and corrective action.
- Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing processes.
- Handle deviation, complaints and OOS in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
- Team member in L1 and provide Quality inputs in CCRs.
Job Requirements
Knowledge/ Education / Previous Experience Required :
- Bachelor Pharmacy degree.
- Minimum one year of experience in similar field.
- Good level of English in terms of speaking, writing and reading.
- Computer Skills (Microsoft office).
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