Lead – Production QMS

Experience: Not Available to Not Available years

Location: R&d; - Zrc|zyd.biologics-2, Ahmedabad, Gujarat, India

Skills: Trackwise, root cause analysis, 6M, 5 Why, cGMP, MFRs, BMRs, SOPs, risk assessments, biotherapeutics manufacturing, regulatory compliance

Oversight of Investigations:
Lead and guide investigations into deviations, OOS, and OOT cases. Ensure closure through comprehensive reports. Demonstrate expertise in root cause analysis tools such as the 6M and 5 Why methodologies, and mentor team members in their application.

Quality Systems Management:
Supervise and approve change controls, CAPAs, and deviations within the Trackwise application. Ensure compliance and efficiency by leveraging at least one year of hands-on Trackwise experience, while supporting team training and best practices.

Documentation Leadership:
Review, approve, and ensure accuracy of cGMP documents including MFRs, BMRs, SOPs, risk assessments, and investigation reports.



Drive continuous improvement in documentation standards.

Cross-Functional Collaboration:
Communicate effectively with cross-functional teams (CFT) to ensure timely closure of QMS documents. Provide explicit direction and foster collaboration, with fluency in English for global communication.

Regulatory & Guideline Compliance:
Stay updated with current regulatory guidelines and industry best practices for QMS activities. Ensure the team’s processes align with evolving standards.

Technical Knowledge in Biotech Manufacturing:
Possess foundational knowledge of upstream and downstream processes in biotherapeutics manufacturing, enabling effective oversight of QMS activities in a DS biotech plant environment. Candidates having exposure to regulatory requirement of documentation and cGMP is essential.

📌 Lead – Production QMS (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad