Officer

• Preparation & Review of SOPs of QA system and review / approval of SOPs of other departments.
• Review of master BMR/BPR of commercial and exhibit batches. Review of BMR / BPR, scale-up and placebo batches.
• Review of executed BMR/BPR of commercial and exhibit batches for batch release.
• Issuance, Retrieval & Destruction of SOPs, STP, specification, BMR/BPR, annexures & other formats.
• Login and review of quality system documents such as Deviation and IPOOS.
• In-process Quality Assurance during Production / Packing activities.
• Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.)
• Review of qualification / validation documents, stability data and Executed documents.
• Participation in investigation of failures and release of batches.
• Shop floor monitoring and ensuring the compliance as per designed procedures.

Preparation, review and tracking of hold time protocols / reports

Work Experience

5 to 8 year

Education

Graduation in Pharmacy

Competencies