Quality Control Analyst

Roles & Responsibilities:

• Perform analysis of raw materials, packing materials, in-process samples, finished products, and stability samples as per approved specifications and test methods.
• Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, and other laboratory equipment.
• Prepare, standardize, and maintain laboratory reagents, volumetric solutions, and reference standards.
• Review analytical data, maintain laboratory records, and ensure compliance with GDP, GLP, and data integrity requirements.
• Investigate OOS, OOT, laboratory incidents, and deviations as per approved procedures.
• Participate in method verification, method transfer, and analytical method validation activities.
• Ensure timely completion of sample analysis and reporting.
• Support regulatory audits, customer audits, and internal audits.
• Follow cGMP, safety, and quality systems requirements.

Roles & Responsibilities:

• Perform microbiological testing of raw materials, finished products, purified water, and environmental monitoring samples.
• Conduct environmental monitoring of manufacturing areas, including viable and non-viable monitoring.
• Perform microbial limit tests, sterility testing, endotoxin testing, and growth promotion tests.
• Prepare and manage microbiological culture media and microbial cultures.
• Carry out water system monitoring and trend analysis.
• Maintain microbiology laboratory records in compliance with GDP, GLP, cGMP, and data integrity requirements.
• Investigate OOS, OOT, deviations, and microbiological excursions.
• Participate in method validation, method suitability studies, and qualification activities.
• Ensure laboratory housekeeping, equipment calibration, and compliance with safety requirements.
• Support internal, regulatory, and customer audits.

B.Sc./M.Sc. (Chemistry/Analytical Chemistry/Microbiology/Biotechnology) or equivalent qualification.

2-4 Years of relevant experience in a pharmaceutical formulation/API manufacturing company.

• Knowledge of cGMP, GLP, GDP, and Data Integrity.
• Hands-on experience with analytical instruments (for QC Analyst) and microbiological testing techniques (for Microbiologist).
• Good documentation and investigation skills.
• Exposure to regulatory requirements of USFDA, MHRA, EU GMP, WHO GMP, etc.