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, Valuable 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 co

📌 In-Process Quality Assurance (India)
🏢 Meril
📍 India