Zydus Biologics Unit, a part of Zydus Lifesciences Limited, is hiring for a Section Head/IC role in the Quality Management Systems (QMS) department. This is a fantastic opportunity for professionals looking to grow their careers in the biopharmaceutical industry.
✅About the Role
As a Section Head/IC in QMS, you’ll be responsible for conducting investigations, managing QMS documentation, and preparing essential cGMP documents. You’ll collaborate with cross-functional teams to ensure the timely closure of QMS documents and maintain a strong understanding of current QMS guidelines and regulatory expectations.
✅Key Responsibilities
Conduct Investigations: Prepare reports to close deviations, OOS, and OOT cases using methodologies like 6M and 5 Whys.
Manage QMS Documentation: Use Trackwise to manage Change Control, CAPA, and Deviation documentation (minimum 1 year of experience required).
Prepare cGMP Documents: Create essential documents, including MFRs, BMRs, SOPs, Risk Assessments, and Investigation Reports.
Collaborate with Cross-Functional Teams: Ensure timely closure of QMS documents and maintain effective communication.
Regulatory Compliance: Stay up-to-date with current QMS guidelines and regulatory expectations.
✅Requirements
Education: M.Tech./B.Tech./M.Sc. in Biotechnology, Biochemistry, Microbiology, or related fields.
Experience: 3-15 years of experience in the biopharmaceutical industry.
Skills:
Strong command of the English language.
Sound understanding of QMS guidelines and regulatory expectations.
Basic knowledge of upstream and downstream processes in biotherapeutics manufacturing is preferred.
✅What We Offer
Opportunity to work with a leading biopharmaceutical company.
Collaborative and dynamic work environment.
Professional development and growth opportunities.
📩 How to Apply
If you believe this role aligns with your experience and aspirations, send your profile to:
👉 neha.v.patel@zyduslife.com
