Quality Control Analyst

Role & responsibilities

1. Ensures that work is compliant with GLP & CGMP.
2. Be responsible for work area cleanliness.
3. All other duties as assigned.
4. Familiarity with stability testing and preparation of protocols and reports.
5. Familiarity with analytical testing techniques using HPLC/GC/FTIR/UV and familiarity with any of the CDS software (Labsolutions/ Chromeleon/ Empower).
6. Preparation of Annual product reviews
7. Interaction with operations, product release and logistics group to ensure timely release of analytical data
8. Responsible for execution of qualification and validation of laboratory equipment, instruments.
9. Responsible for Method Verification/ Method Validation as per the requirement.
10. Responsible for analysis of starting materials (APIs, Excipients, etc), packaging materials, intermediate, bulk and finished products analysis.
1. Maintaining the turn around time as per the agreed timelines for testing and releasing the samples
11. Responsible for review of analytical data of APIs, Excipients, Finished product, validation samples, calibration reports, etc.
12. Responsible for preparation and review of COAs.
13. Responsible for preparation of specifications, sampling instructions, test methods and other Quality Control procedures.
14. Responsible for maintenance of lab as per CGMP compliance.
15. Responsible for preparation investigation report OOS, OOT and Incident management.
16. Responsible for continuous improvement in the laboratory testing compliance.
17. Responsible for testing of stability sample within window period.
18. Responsible for preparation of all type of quality control trends reports.
19. Responsible for Good Documentation practices during reporting and documentation.
20. To ensure Safety norms as per EHS policy of the site, meet 100% guidelines.
21. Shall be responsible for quality control operational excellence.
22. Shall be accountable for timely completion of SOP and CGMP training.
23. Shall be responsible for writing SOPs or guidelines for the use of analytical equipment and to describe Laboratory working practices
24. Should have a keen eye for detail and is readily able to identify procedural or GMP errors within the laboratory.
25. Required to write procedures and / or reports for Laboratory working practices.

OTHERS:

• Ensure:
• Compliance related to Environment Health and Safety (EHS) norms at all times.
• CGXP
• Highest level of Data Integrity at all times.
• In case of any abnormality found / observed, immediately escalate it to immediate supervisor or HR Department.