Manager – Quality Assurance

Lupin; Pune District, Pimpri-Chinchwad; Sur place; INR 1 800 000 - 3 200 000; Plein temps

Résumé du poste

Lupin in Pune is seeking an experienced Biopharma QA professional to supervise day-to-day IPQA activities and oversee critical manufacturing steps from dispensing to batch release. You will coordinate with Drug Product teams to ensure smooth execution and compliance with regulatory guidelines.

Responsibilities include reviewing media fill, process validation, cleaning validation, APQR, and ensuring cGMP standards at CMOs. 10–15 years of Biopharma experience and advanced degrees are required.

Qualifications

• 10-15 years of relevant work experience in Biopharma.
• Experience reviewing technical documents related to drug product manufacturing.
• Strong knowledge of cGMP and regulatory guidelines.

Responsabilités

• Monitor day-to-day activities and plan allocation of IPQA personnel as per batch schedule.
• Oversee critical manufacturing activities including dispensing, in-process checks, sampling, filling, sealing, visual inspection, and AQL.
• Coordinate with DP teams for smooth batch execution from dispensing to dispatch.
• Review media fill protocols and reports for compliance with current regulatory guidelines.
• Review process validation and cleaning validation protocols and reports.
• Ensure availability of visual inspection qualification kits.
• Review and approve APQR reports for products manufactured at CMOs.
• Manage market complaints including registration, communication with complainants and CAPA.

Connaissances

IPQA coordination

Quality systems

Regulatory compliance

cGMP compliance

Documentation review

Formation

Masters in Biotechnology or Biopharmaceutics

Post Graduation in Pharmacy

Description du poste

Job Description

• Monitor day-to-day activities and plan allocation of IPQA personnel as per batch schedule. Oversee critical manufacturing activities including dispensing, in-process checks, sampling, filling, sealing, visual inspection, and AQL.
• Coordinate with Drug Product (DP) teams for smooth batch execution from dispensing to dispatch.

Review technical documents related to drug product manufacturing.

Media Fill, Validation, and Qualification

• Review media fill protocols and reports in compliance with current regulatory guidelines. Ensure equipment and area qualifications, including periodic requalification for drug product facilities.
• Review process validation and cleaning validation protocols and reports.

Ensure availability of visual inspection qualification kits.

Contract Manufacturing Organizations (CMOs) Activities

• Ensure manufacturing and analytical activities at CMOs are conducted in compliance with Quality Technical Agreements and cGMP requirements.
• Coordinate and communicate with CMO manufacturing and analytical teams for timely execution and tracking of activities.
• Identify the need for new procedures and ensure their implementation; perform gap analysis of existing procedures.
• Review executed Batch Processing Records (BPR) and Analytical Records (AR) for batch release, and coordinate with CMOs to ensure compliance.
• Review and approve Annual Product Quality Review (APQR) reports for products manufactured at CMOs.

Market Complaint and Recall Activities

• Manage market complaints including registration, communication with complainants and DSRM, investigation, and implementation of corrective and preventive actions (CAPA).
• Notify stakeholders regarding product or batch recalls/market withdrawals.

Work Experience

10-15 Years of relevant work experience in Biopharma

Education

Masters in Biotechnology or Biopharmaceutics

Post Graduation in Pharmacy

Competencies