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.

Strong understanding of cGMP, Quality Management Systems (QMS), Positive 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