Quality Control - API Division - Visakhapatnam, Andhra Pradesh

Qualifications & Experience:

• Master's Degree (M.Sc.) in Microbiology / Chemistry
• Experience : 3-8Yrs

Job Description:

Microbiology:

• Perform microbiological testing of raw materials, purified water, environmental monitoring samples, compressed air, and finished APIs as per approved procedures.
• Conduct microbial limit tests, bioburden testing, endotoxin testing, and microbial identification.
• Monitor and trend environmental monitoring results for cleanrooms and controlled areas.

HPLC Analysis:

• Perform analysis of raw materials, intermediates, and APIs using HPLC and other analytical instruments.
• Prepare mobile phases, standard solutions, and test solutions according to approved methods.
• Execute method verification, method transfer, and instrument calibration activities.

Quality Management System (QMS):

• Manage deviations, change controls, CAPA, incident investigations, and risk assessments.
• Participate in internal audits and regulatory inspections.
• Prepare, review, and update SOPs, specifications, protocols, and reports.
• Ensure compliance with cGMP, ICH, WHO, USFDA, MHRA, and other regulatory requirements.