Job Description

Senior Manager / Manager – Development Quality Assurance (DQA)

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Location: Vapi, Gujarat

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Experience: 10 –15 Years

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Job Summary

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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 robust 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.

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Key Responsibilities:

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- Prepare, review, revise, and periodically update Quality Assurance SOPs, templates, formats, and other controlled quality documents supporting R&D; activities.
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- Establish, implement, maintain, and continuously improve the Development Quality Assurance (DQA) system.
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- Develop and implement quality procedures supporting process development, analytical development, formulation development,



technology transfer, process characterization, and stability studies.
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- 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.
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- Provide independent quality oversight to ensure compliance with approved procedures, Good Documentation Practices (GDP), ALCOA+ principles, internal quality standards, and applicable regulatory requirements.
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- 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.
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- Review laboratory notebooks, electronic laboratory records, worksheets, raw data, chromatograms, cal

📌 Development Quality Assurance (Jamnagar)
🏢 Meril
📍 Jamnagar