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

Role Overview

We seek a seasoned Senior Manager or Manager in In-Process Quality Assurance to lead and supervise quality-related activities throughout manufacturing operations at our facility in Vapi, Gujarat. The candidate will have extensive expertise in biologics or Cell & Gene Therapy (CGT) manufacturing processes with a focus on compliance with current Good Manufacturing Practices (cGMP), regulatory standards, Good Documentation Practices (GDP), and ALCOA+ principles for data integrity.

Primary Duties

• Develop, review, update, and maintain QA Standard Operating Procedures (SOPs), templates, and documentation related to IPQA functions.
• Conduct line clearance prior to manufacturing runs and material release, ensuring readiness of production areas, equipment sanitation, and avoidance of cross-contamination or mix-ups.
• Oversee manufacturing processes to confirm adherence to approved protocols, monitoring critical process parameters and key quality attributes, alongside in-process controls.
• Track identification and status of raw materials, intermediates, equipment, production zones, and bulk products during manufacturing cycles.
• Manage dispensing, reconciliation, labeling, storage, and traceability processes for both materials and finished goods.
• Examine batch manufacturing records, cleaning logs, equipment usage, and associated documentation for accuracy and compliance.
• Validate in-process test results, manufacturing data, material reconciliations, and batch documents before quality assurance batch decisions.
• Assess batch release documentation including Certificates of Analysis and Compliance.
• Perform routine GMP inspections on the shop floor to assess personnel conduct, gowning practices, documentation standards, equipment condition, and material flow.
• Uphold Good Documentation Practices and the integrity of data in accordance with ALCOA+ principles.
• Identify, report, and investigate deviations, non-conformities, documentation discrepancies, and GMP lapses.
• Engage in root cause analyses, deviation investigations, corrective and preventive actions (CAPA), and verify their effectiveness and implementation.
• Confirm the execution of approved change controls that affect manufacturing processes.
• Ensure the completion and proper conduct of equipment and line cleaning and verification protocols.
• Offer GMP-related guidance and quality management oversight to manufacturing teams.
• Support quality assurance aspects of media fills, engineering batches, process validations, cleaning validations, and technology transfer activities.
• Maintain documentation ready for inspections and ensure adherence to document control systems.
• Monitor key IPQA quality metrics including deviations, Right First Time rates, audit findings, documentation errors, CAPA effectiveness, and batch review timelines, fostering continuous quality improvements.

Required Qualifications and Experience

• A postgraduate degree in Pharmacy (M.Pharm), Technology (M.Tech), or Science (M.Sc.) with specialization in Biologics or Cell & Gene Therapy.
• Minimum of 10 to 15 years’ professional experience in In-Process Quality Assurance activities within pharmaceutical, biotechnology, or biopharmaceutical sectors.
• Comprehensive knowledge of cGMP standards, Quality Management Systems (QMS), GDP, and ALCOA+ compliance.
• Practical expertise in manufacturing quality control, batch record evaluations, deviation handling, CAPA, change management, validation, and technology transfers.
• Strong abilities in problem resolution, clear communication, thorough documentation, and collaborative cross-functional work.