QC 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.

Microbiologist - 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.

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

Experience

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

Skills Required

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

📌 Quality Control Analyst (Baddi)
🏢 Zydus Lifesciences
📍 Baddi