Officer

Lupin; Pithampur; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin India is seeking an experienced QA professional to prepare, review, and approve SOPs for the QA system and coordinate with other departments.

The role involves reviewing master BMR/BPR for commercial and exhibit batches, participating in investigations, and ensuring in-process QA during production and packing. You will monitor shop floor compliance and manage hold time protocols.

Qualifications

• Bachelor-level pharmacy degree with QA exposure.
• Experience in SOP preparation and QA systems.
• Knowledge of BMR/BPR review and batch release processes.

Responsibilities

• Prepare & review SOPs for QA system and approve SOPs for other departments.
• Review master BMR/BPR for commercial and exhibit batches; review BMR/BPR, scale-up and placebo batches.
• Review executed BMR/BPR for batch release.
• Issue, retrieve & destroy SOPs, STP, specifications, BMR/BPR and related formats.
• Login and review quality system documents like deviations and IPOOS.
• Provide in-process QA during production and packing activities.
• Sampling at various stages of manufacturing/packing as required.
• Review qualification/validation documents, stability data and executed docs.
• Participate in investigations of failures and batch release.
• Shop floor monitoring to ensure compliance with procedures.
• Prepare, review and tracking of hold time protocols/reports.

Skills

QA documentation

SOP review

GxP compliance

Quality Assurance

Shop floor monitoring

Education

Graduation in Pharmacy

Job description

• Preparation & Review of SOP’s of QA system and review / approval of SOP’s 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 SOP’s, 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

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