Zenfold Sustainable Technologies (ZST) is Hiring!
- Developmental Quality Assurance (DQA) – Specialist / Executive / Manager
- Location: Bengaluru | DQA – Product Development / R&D QA
- Required Qualifications
- B.Sc/M.Sc (Chemistry) or B.Pharm/M.Pharm
- 3–12 years in DQA / R&D QA / Development QA (API industry)
- Hands-on experience in documentation review, DI compliance, ICH Q8–Q11
- Reporting to: Chief Scientific Officer (CSO)
Position Overview
ZST is looking for an experienced Developmental Quality Assurance (DQA) professional to strengthen quality systems across API development, covering Process Development, Analytical R&D, scale-up, and Tech Transfer.
The role ensures QbD-driven development, regulatory compliance, and end-to-end data integrity across the product lifecycle.
Key Responsibilities (Expanded Version)
1️⃣ Quality Oversight for API Development
End-to-end QA oversight for R&D, Process Development, AR&D activities.
Review development protocols, experiment plans, study reports, PDRs.
Ensure traceable, accurate, ALCOA+ compliant data across lab, kilo-lab, pilot.
2️⃣ QbD & Risk-Based Development
Implement QbD elements: QTPP, CQAs, CMAs, CPPs, risk assessments.
Review and guide DoE plans, interpretation, and reporting.
Support development of control strategies aligned with ICH Q8–Q11.
3️⃣ Documentation, SOPs & Data Integrity
Prepare/review SOPs, templates, formats, checklists for DQA & TT.
Strengthen data governance and enforce ALCOA+ practices. Review notebooks, lab records, chromatograms, raw data, and stability datasets.
4️⃣ Technology Transfer (TT) & Scale-Up Support
Prepare/review comprehensive Technology Transfer packages.
Ensure readiness of development batches for kilo, pilot, and commercial scale. Work with Manufacturing, QA/QC, Engineering for smooth handover.
Support troubleshooting during scale-up, qualification, and validation.
5️⃣ Compliance, Audits & Regulatory Interface
Ensure development aligns with GMP, GLP, ICH and global expectations.
Participate in internal audits, client audits, regulatory inspections as SME.
Contribute to CMC dossiers, development sections, risk summaries.
To Apply Send your CV to: shravankumar.k@zenfoldst.com
