Posted:1 week ago|
Platform:
Work from Office
Full Time
1.Involved in preparation, review and approval of documents related to Quality control includes COA,STP,
SPE, DRS, MOA, SOP, and Protocol.
2. Ensure timely analysis and release of RM/PM/CM, DS, DP, IPQC samples, Plasma samples.
3. Ensure the operation, calibration, maintenance, qualification, validation of instrument as per the defined
procedure.
4. Ensure reference Standard / Working Standard Management and control. 5. Review of Log Book, Calibration Records and Volumetric/Test Solutions Records but not limited to as when
required.
6. Co-ordination with cross functional team like QA, Production, Engineering, Purchase, Finance, Regulatory, ADL/R&D, IT, HR as when required.
7. Involved in QMS documentation and Ensure timely of closure of Deviation, change control, Incident,
CAPA.
8. Ensure Stability study Management as per the regulatory requirements.
9. Involved in Analytical method validation/verification & Technology transfer activity.
Intas
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