Job Opening For Quality Control Department At Zydus

Atharva J February 20, 2025 Quality Control,

Quality Control (QC) Department in the Pharmaceutical Industry

The Quality Control (QC) Department in a pharmaceutical company ensures that raw materials, in-process products, and finished pharmaceutical products meet defined quality standards. It plays a critical role in compliance with Good Manufacturing Practices (GMP) and regulatory requirements (FDA, WHO, EU GMP, etc.).

Key Functions of the QC Department:

1. Raw Material Testing

Testing of Active Pharmaceutical Ingredients (APIs) and excipients before use in production.
Identification, purity, and potency testing as per pharmacopeial standards (USP, BP, IP).
Ensuring raw materials are free from contamination.

2. In-Process Quality Control (IPQC)

Monitoring of intermediate production stages to ensure compliance with process specifications.
Regular sampling and testing during tablet compression, capsule filling, and coating processes.
Ensuring uniformity of weight, hardness, friability, and dissolution rate of tablets.

3. Finished Product Testing

Final testing of dosage forms (tablets, capsules, syrups, injections, etc.) before release.
Ensuring compliance with pharmacopeial standards (USP, BP, IP) and regulatory requirements.
Conducting assay, dissolution, disintegration, uniformity of content, and stability tests.

4. Microbiological Testing

Sterility testing of injectable and ophthalmic products.
Microbial limit testing for non-sterile products.
Endotoxin and pyrogen testing to check for bacterial contamination.
Environmental monitoring in cleanrooms and production areas.

5. Stability Testing

Conducting accelerated and real-time stability studies to determine shelf-life.
Evaluating product degradation under different temperature and humidity conditions.
Ensuring compliance with ICH stability guidelines.

6. Water and Air Quality Testing

Monitoring the quality of purified water, water for injection (WFI), and other utilities.
Testing for microbial contamination and chemical impurities.
Ensuring compliance with WHO and USP guidelines for pharmaceutical water systems.

7. Packaging Material Testing

Checking the quality of primary and secondary packaging materials.
Verifying the integrity of blister packs, bottles, ampoules, and labels.
Ensuring packaging meets regulatory and safety requirements.

8. Documentation & Compliance

Maintaining batch testing records (BTR) and certificate of analysis (CoA) for every batch.
Ensuring compliance with regulatory guidelines (FDA, EMA, WHO, etc.).
Conducting internal audits and assisting in external regulatory inspections.