Are you passionate about Quality Control and Analytical Services? Join HiMedia Laboratories, a leader in life sciences, as a QC Manager and play a pivotal role in ensuring compliance with GLP standards while contributing to the manufacturing and quality control of biological drug substances. This is a fantastic opportunity to advance your career in a dynamic and innovative environment.
Job Location:
Thane, Maharashtra
Primary Job Role:
The QC Manager – Analytical Services will be responsible for implementing and maintaining a GLP-compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products.
Key Responsibilities:
- Implement and maintain a GLP-compliant Quality Management System for buffer preparation, upstream, and downstream processes.
- Oversee closure and investigation of:
- OOS (Out of Specification)
- OOT (Out of Trend)
- Deviations
- Laboratory incidents
- Manage the CAPA system, including changes, deviations, and non-conformities.
- Coordinate risk assessments.
- Ensure readiness for laboratory inspections by national and international regulatory bodies (e.g., USFDA, UK-MHRA, EU, Local FDA, NABL).
- Manage supplier qualification processes for materials and services.
- Support the review and qualification of instruments, test equipment, and cleanroom facilities.
- Review and approve batch records while ensuring adherence to TAT (Turnaround Time).
- Define and set departmental goals.
- Ensure timely communication with customers and distribution channels.
- Participate in cross-functional projects.
- Review GLP-related documents and ensure compliance.
- Conduct method validation, transfer, and cleaning validation activities.
- Approve and release batches of intermediate products, drug substances, and final products.
- Assess changes related to product components and manufacturing/site transfers.
- Prepare and review SOPs for relevant functions.
- Perform additional activities as assigned by the Head of Department.
Qualifications and Experience:
| Criteria | Details |
|---|---|
| Education | Bachelor’s degree in Life Sciences, Biochemistry, or a related field. An MBA is preferred. |
| Experience | Proven track record in sales within analytical services. 5-10 years of relevant experience is required. |
How to Apply:
Interested candidates meeting the criteria can send their CV with the subject line “Application for Analytical Services – Sales” to:
- Email 1: pvaidya@himedialabs.com
- Email 2: atc.hr@himedialabs.com
