Senior Manager / Manager – In-Process Quality Assurance (IPQA)

Location: Vapi, Gujarat

About the Role

We are looking for an experienced Senior Manager / Manager – In-Process Quality Assurance (IPQA) to oversee quality assurance activities across manufacturing operations. The ideal candidate will have strong experience in Biologics or Cell & Gene Therapy (CGT) manufacturing and will ensure compliance with cGMP, regulatory requirements, Good Documentation Practices (GDP), and ALCOA+ data integrity principles.

The successful candidate will provide quality oversight throughout manufacturing operations, support batch release activities, drive continuous quality improvements, and ensure inspection readiness.

Key Responsibilities

- Prepare, review, revise, and maintain QA SOPs, templates, and quality documents for IPQA activities.
- Perform line clearance before manufacturing and material issuance to ensure area readiness, equipment cleanliness, and prevention of mix-ups or cross-contamination.
- Monitor manufacturing operations to ensure compliance with approved procedures, critical process parameters (CPPs), critical quality attributes (CQAs), and in-process controls.
- Verify identification and status of materials, intermediates, equipment, manufacturing areas, and bulk products throughout production.
- Ensure proper dispensing, reconciliation, labeling, storage, and traceability of materials and finished products.
- Review Batch Manufacturing Records (BMRs), logbooks, cleaning records, equipment usage records, and supporting documentation for completeness and compliance.
- Verify in-process testing results, manufacturing data, reconciliations, and batch documentation before QA batch disposition.
- Review batch release documentation, Certificates of Analysis (CoA), Certificates of Compliance (CoC), and related release records.




- Conduct routine shop-floor GMP inspections to monitor personnel practices, gowning compliance, documentation, equipment status, and material movement.
- Ensure compliance with Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
- Identify, document, investigate, and report deviations, non-conformances, documentation errors, and GMP deficiencies.
- Participate in deviation investigations, root cause analysis, CAPA implementation, and effectiveness verification.
- Verify implementation of approved change controls impacting manufacturing operations.
- Ensure completion and compliance of equipment cleaning, line cleaning, and cleaning verification activities.
- Provide GMP guidance and quality oversight to manufacturing personnel.
- Support media fills, engineering batches, process validation, cleaning validation, and technology transfer activities from a QA perspective.
- Maintain inspection-ready documentation and ensure compliance with document control procedures.
- Monitor IPQA quality metrics, including deviations, Right First Time (RFT), audit observations, documentation errors, CAPA effectiveness, and batch review timelines, while driving continuous improvement initiatives.

Qualifications

- M.Pharm, M.Tech, or M.Sc. with specialization in Biologics or Cell & Gene Therapy (CGT).
- 10–15 years of experience in In-Process Quality Assurance (IPQA) within the pharmaceutical, biotechnology, or biopharmaceutical industry.
- Solid understanding of cGMP, Quality Management Systems (QMS), Good Documentation Practices (GDP), and ALCOA+ data integrity principles.
- Hands-on experience in manufacturing quality oversight, batch record review, deviation investigations, CAPA, change control, validation, and technology transfer.
- Excellent problem-solving, communication, documentation, and cross-functional collaboration skills.

📌 In-Process Quality Assurance (IPQA) (Gujarat)
🏢 Meril
📍 Gujarat