Discover an exciting career opportunity at Zydus Biologics Unit, a division of Zydus Lifesciences Limited, located in the vibrant city of Ahmedabad. We are seeking a skilled Section Head/Individual Contributor (IC) for our Quality Management System (QMS) team in the Production Department. If you are passionate about biotherapeutics manufacturing, excel in QMS documentation, and thrive in collaborative environments, this QMS Section Head job in Ahmedabad is your chance to make a significant impact in the pharmaceutical industry. Join us to drive excellence in cGMP compliance and contribute to innovative biotherapeutics production.
Key Responsibilities
As a Section Head/Individual Contributor in the QMS section, you will play a pivotal role in maintaining high-quality standards in biotherapeutics manufacturing. Your responsibilities will include:
- Conducting thorough investigations and preparing detailed reports to close deviations, OOS (Out of Specification), and OOT (Out of Trend) cases using methodologies like 6M and 5 Whys.
- Managing QMS documentation, including Change Control, CAPA (Corrective and Preventive Actions), and Deviation processes, utilizing TrackWise software (minimum 1 year of experience required).
- Preparing critical cGMP documents such as MFR (Master Formula Record), BMR (Batch Manufacturing Record), SOPs (Standard Operating Procedures), Risk Assessments, and Investigation Reports.
- Collaborating with cross-functional teams to ensure timely closure of QMS documents and compliance with regulatory standards.
- Maintaining clear and professional communication in English to support documentation and team coordination.
- Ensuring adherence to current QMS guidelines and regulatory expectations in biotherapeutics manufacturing.
- Applying basic knowledge of upstream and downstream processes in biotherapeutics production to enhance process efficiency.
Qualifications
To excel in this QMS Section Head role, candidates should possess:
- Education: M.Tech., B.Tech., or M.Sc. in Biotechnology, Biochemistry, or Microbiology.
- Experience: 3 to 15 years in QMS roles within the pharmaceutical or biotechnology industry, with at least 1 year of hands-on experience using TrackWise.
- Strong command of the English language for professional communication and documentation.
- Sound understanding of current QMS guidelines and regulatory expectations in biotherapeutics manufacturing.
- Basic knowledge of upstream and downstream processes in biotherapeutics production (preferred).
- Proven ability to collaborate effectively with cross-functional teams to achieve quality objectives.
Benefits of Joining Zydus Biologics
At Zydus Biologics, we value our employees and offer a supportive environment to foster professional growth:
- Competitive Salary: INR 8,00,000 to INR 18,00,000 per annum, based on experience and qualifications.
- Opportunities to work on cutting-edge biotherapeutics manufacturing projects.
- Access to professional development programs to enhance your skills in QMS and cGMP compliance.
- Collaborative and inclusive work culture in Ahmedabad, a hub for pharmaceutical innovation.
- Comprehensive health and wellness benefits to support your well-being.
How to Apply
If you are ready to take the next step in your career with Zydus Biologics, we invite you to apply for this Section Head QMS job in Ahmedabad. Please send your updated resume and a cover letter to neha.v.patel@zyduslife.com. Ensure your application highlights your experience in QMS documentation, TrackWise, and biotherapeutics manufacturing. Applications are accepted until October 06, 2025. Don’t miss this opportunity to join a leading name in the pharmaceutical industry!
FAQs
Q: What is the experience level required for the Section Head QMS role at Zydus Biologics?
A: Candidates should have 3 to 15 years of experience in QMS roles, with at least 1 year of hands-on experience using TrackWise software.
Q: What types of documents will I be responsible for preparing in this role?
A: You will prepare cGMP documents such as MFR, BMR, SOPs, Risk Assessments, and Investigation Reports, ensuring compliance with regulatory standards.
