Job Description

Key Responsibilities:QC:
1. Responsibilities of Quality Control Laboratory including Instrumental Lab, Chemical Lab.
2. To ensure the compliance of current Good Laboratory Practices and Standard Operating Procedures in the Q.C. Laboratory.
3. To prepare the working standards as per the guidelines and pharmacopoeias.
4. Review of QC documents, test protocols and analytical reports.
5. To carry out the sampling and testing of raw material and packing material according to approved procedure.
6. Responsibilities for testing and approval or rejection of packaging materials after discussion with QC Head.
7. To recommend the release of Raw Material and Packing Material in standard format
8. To intimate the Officer Stores and QC Head for the failure of any packing material, however, if the QC Head is absent then intimate the status of the same to G.M Technical/Director.
9. To record all the data related to the testing on line on day-to-day basis and ensuring the traceability of it.
10. To ensure the status tag on the released material and transfer of such material in the released area.
11. To review and updating of all SOPs as per requirements of GLP on regular basis.
12. To participate in execution of all validation program like process validation, cleaning validation, analytical method validation, etc.
13. To check the cleaning records of laboratory.
14. To make documentation of all analysis including raw data, checking of all data and proper storage of data.
15. To charge the product for stability and analysis of all stability samples, and compilation of stability data.
16. To provide response to queries received from regulatory / marketing departments.
17. To maintain the calibration record and annual maintenance contract records of all the instruments in QC Laboratory.
18. To ensure the timely review and updating of all standard test procedures and specifications of raw materials and packaging materials on regular basis to meet regulatory requirements.
19. To ensure the standardization of volumetric solution, preparation of reagents as per schedule and verification of its documentation.
20. To develop the new analytical method and Standard Testing Procedures (STPs) for in-house or pharmacopoeia methods and prepare the method validation report.
21. To maintain the record of retain sample by means of their inventory, their periodic check and their disposal.
22. To train and develop all QC staff on GLP & advanced analytical techniques and their evaluation on periodical basis.
23. To evaluate the requirements of HPLC/GC columns, reference standards, chemicals, reagents, etc and raise PR for procurement of the same.
24. In absence of QC Head take care of the day to day activities of QC department, including approval of documents and release of material.
25. If you take leave, your work responsibility handover to other QC Executive / Officer.
Authority
1. To carry out all the necessary test and recording their result thereof for all the material.
2. To check the stores and ensure the implementation of GMP norms in the stores.
3. Not to allow any material inside the plant if material is not from the approved vendor or if it is not as per the specified standards.

Kaapro Management Solutions