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Assistant Manager Quality Assurance- Pharma

3 months ago

Vadodara, Gujarat, India Paradise Placement Consultancy Full time

Responsibilities

:

Ø Review and approval of SMF, VMP and Quality manual.

Ø Review and approval of BMR, BPR, MFC.

Ø Review and approval of OOS/OOT.

Ø Review and approval of Vendor list.

Ø Planning, execution and compliance of both internal and externalaudits.

Ø Review and approval of all Quality Assurance, quality Control and manufacturing records.

Ø Review of filled BMR/BPR and analysis data, and release of batch for dispatch.

Ø Review and approval of SOPs.

Ø To prepare audit and compliance reports and CAPA reports.

Ø Review and approval of Qualification Documents.

Ø To review and approval of Change control.

Ø Review and approval of Deviation, Incidence.

Ø Review and approval of APQR.

Ø Review and approval of Method of analysis, Specification, Stability report, Technology transfer and Modification of area.

Ø Review and approval of hold time study protocol and report.

Ø Review, approval and Implementation of CAPA.

Ø To review, assessment and closer of market complaint and product recall.

Ø Review of pest control and rodent control.

Ø Training.

Ø To handle all regulatory, FDA and cGMP audits of customer.

Ø Review the documents and data control.

Ø Review and approval of all validation documents.

Ø To review, monitor IPQA activities.

Key Skills :

Bmr Mfc Bpr Internal Audit External Audit Sops Documentation