- Set up and validate Quality Control laboratories, including chemical, instrumentation, and microbiology labs.
- Develop, implement, and maintain SOPs, test methods, and quality protocols.
-Ensure compliance with cGMP, WHO, , and other international regulatory requirements.
2. Analytical Testing & Method Validatio
n
- Oversee analysis of raw materials, packaging materials, in-process samples, and finished products.
- Ensure timely release of materials and products while maintaining strict adherence to quality specifications.
3.instrumentation & Technology Management
- Oversee qualification, calibration, and maintenance of critical instruments (HPLC,, etc.).
4. Regulatory Compliance & Audit Readiness
- Prepare and maintain documentation for regulatory inspections and audits.
- Liaise with QA, production, and regulatory affairs for submission data and compliance requirements.
5. Team Leadership & Training
- Build, train, and mentor a strong QC team across different sections (Chemical, Instrumental, Microbiology, Stability).
- Conduct regular training programs on analytical techniques, data integrity, and cGMP.
- Foster a culture of continuous improvement and compliance.
Key Skills & Competencies
Strong knowledge of cGMP, and global regulatory standards.
Expertise in analytical testing, stability studies, and method validation.
Hands-on experience with sophisticated analytical instruments (HPLC, GC, FTIR, etc.).
Strong leadership and people management skills with experience in building QC teams.
Ability to work in a start-up environment and establish QC systems from scratch.
Excellent documentation and communication skills.
Qualifications & Experience
- B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or Analytical Chemistry.
- 10+ years of experience in Quality Control in pharmaceutical manufacturing.
- Must have handled both Injectable dosage forms.
- Experience in setting up QC labs for new manufacturing facilities will be highly preferred
Job Types: Full-time, Permanent
Pay: From ?1,000,000.00 per month
Benefits:
Health insurance
Provident Fund
Work Location: In person
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