Quality Control Executive

Roles and Responsibilities of Executive Quality Control


1. Responsible for monitoring of basic norms of cGMP, data integrity, GDP, safety & to maintain his personal health and hygiene.

2. QMS tool shall be initiated In case of any OOT, OOS, Deviation or incidence, gaps in procedure or error observed and same will be reported to concern department head and QA.

3. To participate in QMS investigation of OOS, OOT, incidence, OOC and deviation to identify assignable root cause.

4. Adoption of good laboratory practices and good documentation practices in the laboratory.

5. Responsible for development of Analytical methods for drug substance & drug product

6. Responsible for Analytical Method Validation, Method Verification of drugs substance &drug products.

7. To execute the multimedia dissolution of drug product.

8. To execute routine analysis of development batches, validation samples, stability samples & hold time study samples.

9. To execute Analytical Method, transfer for drug substance & drug product.
10.To ensure adequate identification and segregation of test samples to avoid mix up and cross contamination.

11. Preparation of Specification and STP for New product, raw material and Packing material and Finish Goods.

12. To workout analytical consumable like Reference Standard, Impurity Standard, Working, Standard, HPLC column, and Chemicals.

13. To check the Analytical Documents of ADL.