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, Positive 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 ac

📌 Development Quality Assurance (Junagadh)
🏢 Meril
📍 Junagadh