Job Details - Find Your Perfect Career Opportunity

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.

• 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.

• 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), 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.