QMS Specialist

Role & responsibilities

1. Quality review of QC lab generated data and documentation for accuracy, completeness, and compliance in timely manner to meet the manufacturing schedules/ supply chain requirements.

2. Audit trails review of analytical instrumentation to ensure data integrity.

3. Raw data review for documented information such as calculation verification, standard/sample preparation, reagent preparation, instrument calibration, reagent expires, logbook entries, control charts, etc.

4. Facilitates laboratory data or documentation corrections with analysts to ensure accuracy.

5. Must have a working knowledge of the analytical instrumentations (HPLC, GC, UV-Vis, FTIR, KF, etc.) and able to understand and interpret chromatographic and other analytical data.

6. Should have good command on Chromatographic Data Systems (Chromeleone/ Empower/ Labsolutions) software

7. Assist laboratory to investigate any Out of Specification (OOS) and Out of Trend (OOT) results and deviations.

8. Must be able to perform the trend analysis for the laboratory test results and suggest and implement CAPAs.

9. Create/ update Standard Operating Procedures (SOPs) as required.

10. Provide support to Quality Assurance to perform Internal cGMP Audits.

11. Completes other duties as assigned by Quality (QA/QC) management.

12. To prepare and check Certificates of Analysis for all lots of finished product, raw materials and packaging materials tested in the QC Department.

13. To provide training and retraining to new or existing laboratory staff on proper laboratory documentation procedures as required and ensure that this is documented according to procedures.

14. To ensure GMP compliance as per local procedures, EU and USFDA guidelines.

15. Assist with overall completion of QC Deviations, Errors, CAPA plans, Change controls and Risk Assessment.

16. Responsible for preparation and / review of SOPs.

17. Responsible for evaluation of change management system and adequacy of implementation.

18. Responsible for deviation management and its adequate implementation.

19. Responsible for impact evaluation of Contamination Control Strategy during change control evaluation.

20. Responsible for preparation and / review of QMS trend for Change control, Deviation & CAPA.

21. Responsible for preparation and co-ordination of Quality Management Review meet.

22. Responsible for adequate document management.

23. Responsible for investigation of QMS, co-ordination and support to increase closure rate of QMS documents (i.e. OOS, OOT, Change control, CAPA, Deviation, Incidents, etc).

24. To ensure site investigation has performed with highest level of efforts, GMP investigation tools to identify the cause of failure and robust CAPA.

25. Responsible for tracking of all QC related CAPA, its effectiveness check and its compliance verification.

26. To ensure compliance and effective implementation of all departmental procedures.

27. To review Calibration and qualification data for QC Laboratory Equipment/ Instruments.

28. Responsible for continuous improvement in the warehouse department compliance.

29. To ensure Safety norms as per EHS policy of the site, meet 100% guidelines.

30. Shall be responsible for quality control operational excellence.

31. Shall be accountable for timely completion of SOP and CGMP training.