Manager – Quality Assurance

Lupin Ltd; Pune District, Pimpri-Chinchwad; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Lupin Ltd in Pune seeks an experienced GMP Compliance professional for Drug Product facilities. You will oversee IPQA planning, dispensing, in-process checks, sampling, filling, sealing, and visual inspection to ensure batch quality.

Coordinate with DP teams for seamless batch execution from dispensing to dispatch. Review drug product manufacturing docs, reliability of media fill and validation protocols, and ensure qualifications.

Qualifications

• 10-15 Years of relevant work experience in Biopharma.
• Masters in Biotechnology or Biopharmaceutics.
• Post Graduation in Pharmacy.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Skills

GMP Compliance

IPQA Planning

QA Documentation

Batch Release

CMO Coordination

CAPA Management

Market Complaints

Education

Masters in Biotechnology

Post Graduation in Pharmacy

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.

Job Description

GMP Compliance – Drug Product Facility

• 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

GMP Compliance – Drug Product Facility

• 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.