QA

Vendor Management, Contract testing laboratories qualification, Qualification and management of contract vendors and external service providers, QMS and compliance.

Responsible to handle the team to achieve the set targets and maintain qualitative, quantitative as well as cGMP aspects.

Alembic Pharmaceuticals Ltd. Is looking for competent professionals with USFDA exposure to be an integral part of our site at Karkhadi and Panelav-near Vadodara

Candidate should have experience in the field of Analytical Research and Development Involved in Analytical Method development & validations, Stability analysis, Regular analysis activities.

B.Pharm/ M.Sc; Analytical QA activities mainly to review and maintain GLP in QC review of analytical report of RM,IP,FP and stabilty data.

B. Pharma/ B. Sc/ M. Sc; Knowledge of STP/SOP, BMR/BPR, hold time study, Product Transfer, process validation, protocol preparation

Handling of QMS activities like Deviation, Incident, Investigation, CCP, Protocol Preparation, Risk Assessment etc.

B.Pharmacy / M.Pharma / M.Sc; Candidate should have experience in IPQA activities for Manufacturing and Packing area. Candidate should have experience Injectable/ Parenteral IPQA activities specially for SVP line or Oncology facility.

M.Pharm/ B.Pharm/ M.Sc; Oversee ampoule line, liquid vial line, dry powder line, and media simulation studies. Monitor and record the temperature, differential pressure, relative humidity (RH), and environmental conditions in the aseptic area of the microbiology testing area. Manage stock of dehydrated culture media, prepared media plates, and test tubes.