Work from Office
Full Time
1) Supervise compliance to all cGMP, GxP, or any other regulatory requirements, Including EH&S requirements.
2) Execute and supervise all tasks and activities as per the applicable SOPs.
3) Complete self-training and monitor training of team members on the relevant SOPs.
4) Report any quality concerns or suggestions for improvements to Managers.
5) Review of Master document such as Validation protocol and reports.
6) Review and monitoring of Quality system document such as deviation, change control, OOS, OOT, Vendor complaint, CAPA, Risk assessment, Non conformities, Internal Audit & Market Complaint.
7) Ensure preparation and periodic review / updation of APQR.
8) Preparation & Review of Quality Assurance SOPs.
9) Review other Department SOPs.
10) Review of Executed BMR/BPR.
11) Participation in investigation of failures.
12) Participation in aseptic process simulation, cleaning validation and review of related documents
and visual observations of Media fill vials.
13) In-process Quality Assurance during production activity and sampling at different stages of
processing / packing as per requirement.
14) Monitoring and review of Quality system documents such as Deviation, Change control, OOS,
OOT and CAPA.
15) Review of Master documents such as e-BPR, filter validation documents.
16) Review of stability study protocol and stability study reports
5-6 years
Lupin
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