Role & responsibilities
- Manage day-to-day operations of the Quality Control laboratory for sterile injectable products.
- Ensure compliance with US FDA, cGMP, ICH, WHO, and applicable regulatory guidelines.
- Review and approve analytical data, Certificates of Analysis (COA), specifications, protocols, and laboratory reports.
- Oversee testing of raw materials, packaging materials, in-process samples, finished products, and stability samples.
- Supervise microbiology activities including environmental monitoring, water testing, sterility testing, endotoxin testing, and microbial limit testing.
- Ensure calibration, qualification, and maintenance of laboratory instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, TOC Analyzer, Dissolution Apparatus, and other analytical equipment.
- Lead laboratory investigations including OOS (Out of Specification), OOT (Out of Trend), deviations, CAPA, change controls, and risk assessments.
- Review analytical method validation, method transfer, and verification activities.




- Support regulatory inspections and customer audits, including US FDA, MHRA, EU GMP, WHO, and other international agencies.
- Ensure data integrity compliance in accordance with ALCOA+ principles and 21 CFR Part 11 requirements.
- Manage stability studies according to ICH guidelines.
- Develop, review, and approve SOPs, specifications, protocols, and quality documentation.
- Train, mentor, and develop QC personnel while fostering a culture of quality and continuous improvement.
- Coordinate with QA, Production, Engineering, Warehouse, and Regulatory Affairs to ensure smooth product release and compliance.

Preferred candidate profile
- Experience with aseptic manufacturing and sterile injectable dosage forms.
- Exposure to technology transfer and recent product commercialization.
- Experience supporting successful US FDA inspections with no critical observations.

📌 Quality Control Manager (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh