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Key Responsibilities:
1) Assigned for Raw materials analysis (API, Auxiliary and Primary packing).
2) Monitoring release cycle time KPI for Raw materials unit.
3) Coordinate with supply chain and production regarding material release demand.
4) Coach raw materials analysts’ team and follow-up release weekly plan for each analyst.
5) Assisting Lab Head in organizing work in unit through DCM board.
6) Change control creation, expert assessment follow-up and actions implementation confirmation.
7) Specification creation & reviewing to comply with current pharmacopoeias and regulatory requirements.
8) Release cycle time management for routine testing of raw/packaging materials.
9)Lead OOS investigations to reach possible root causes and suggesting
CAPA.
10)Performing Nitrogen and Compressed Air analysis .
11) Implementation of gap analysis for all raw materials, aiming for full monograph testing.
12) Issuing, reviewing and updating relevant SOP's.
13) Responsible for reduced testing for materials supplied to site.
14) Self inspection activities in QC and Sampling area.
15) SAP system expert user (QM module).
JOB-HOLDER’s ENTRY REQUIREMENTS:
Education:
Related Experience:
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competencies:
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