Senior Manager / Manager – Development Quality Assurance (DQA)
Location: Vapi, Gujarat
Experience: 10 –15 Years

Job Summary
We are seeking an experienced Senior Manager / Manager – Development Quality Assurance (DQA) to establish, maintain, and continuously improve the Development Quality Assurance (DQA) system supporting Research & Development activities. The ideal candidate should have strong expertise in Biologics or Cell & Gene Therapy (CGT), with extensive experience in quality systems, regulatory compliance, data integrity, and quality oversight across the product development lifecycle.
Key Responsibilities:
Prepare, review, revise, and periodically update Quality Assurance SOPs, templates, formats, and other controlled quality documents supporting R&D; activities.
Establish, implement, maintain, and continuously improve the Development Quality Assurance (DQA) system.
Develop and implement quality procedures supporting process development, analytical development, formulation development, technology transfer, process characterization, and stability studies.




Review R&D; documentation, including SOPs, Work Instructions (WIs), Equipment Operating Procedures (EOPs), specifications, protocols, reports, technical documents, process and analytical development records, method qualification, method transfer, and technology transfer documentation.
Provide independent quality oversight to ensure compliance with approved procedures, Valuable Documentation Practices (GDP), ALCOA+ principles, internal quality standards, and applicable regulatory requirements.
Ensure quality compliance across all product development activities, including process development, analytical method development, validation, qualification, technology transfer, scale-up studies, engineering batches, and stability programs.
Review laboratory notebooks, electronic laboratory records, worksheets, raw data, chromatograms, calculations, instrument printouts, and supporting documentation for accuracy, completene

📌 Development Quality Assurance (India)
🏢 Meril
📍 India