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Zenfold Sustainable Technologies (ZST), a progressive and innovation-driven organization in the pharmaceutical and sustainable technology sector, has announced a hiring opportunity for Developmental QA (DQA) Professionals at multiple levels including Specialist, Executive, and Manager. The position is based in Bengaluru and falls under the QA – Product Development / R&D QA department, reporting directly to the CSO.
This role is ideal for experienced QA professionals with strong exposure to API product development, Quality by Design (QbD), and global regulatory standards.
About the Role
The DQA professional will be responsible for ensuring quality compliance, data integrity, and documentation accuracy throughout R&D, analytical, and process development phases. The role supports QbD-driven development, governance frameworks, and seamless Technology Transfer (TT) from R&D to manufacturing.
Key Responsibilities
Successful candidates will handle end-to-end QA responsibilities related to product and process development. Major tasks include:
Quality Oversight & Compliance
•Provide QA oversight for R&D, analytical, and process development activities.
•Ensure data integrity (ALCOA+), documentation accuracy, and traceability.
•Maintain compliance with ICH Q8–Q11, GMP/GLP, and global regulatory guidelines.
Documentation & Review
•Review development protocols, DoE plans, risk assessments, and raw analytical data.
•Prepare and review SOPs, guidelines, validation plans, chromatograms, PDRs, and lab notebooks.
•Support regulatory dossier sections, documentation practices, and control strategy.
Technology Transfer (TT)
•Prepare and review TT packages.
•Support troubleshooting, scale-up activities, and TT meetings.
Training & Cross-Functional Collaboration
•Train R&D teams on QbD, documentation practices, and data integrity principles.
Qualifications Required
•B.Sc/M.Sc (Chemistry) or B.Pharm/M.Pharm
•3–15 years of experience in DQA, R&D QA, Product Development QA (API industry preferred)
•Strong understanding of QbD, process development, TT, analytical development, and scale-up
•Experience handling SOPs, DoE, TT documents, PDRs, and development data
•Exposure to global regulatory audits and pharma quality systems
Key Skills
•Strong knowledge of GMP/GLP and ICH Q8–Q11 guidelines
•Excellent analytical, documentation, and technical writing skills
•Strong problem-solving abilities and attention to detail
How to Apply
Interested candidates can send their CV to:
📧 shravan kumar.k@zenfoldst.com
Please include:
•Current CTC
•Expected CTC
•Notice Period
