11 - 15 years
10 - 15 Lacs
Posted:1 month ago|
Platform:
Work from Office
Full Time
1. Ensure the data compilation of Analytical Raw Data and its relevant log entries of In-process, Intermediates, Raw Material, Finished products, Hold time study, process validation, cleaning samples, Vendor development.
2. Planning, Monitoring of sampling, analysis and release of raw materials, packing materials and finished goods.
3. Handling of Laboratory incident and assist in the investigation of Out of Specification, Out of calibration and Out of trend results and customer complaints.
4. To coordinate with ADL/R&D for OOS investigation.
5. Responsible for all QMS activities carried out in quality control laboratory and compliance as per existing SOPs, safety and cGLP.
6. Ensuring instruments and equipments calibration as per master schedule and updating of calibration status labels and review of Calibration records.
7. Develop second line leadership within the department as part of succession planning.
8. Co-ordination with Regulatory Affairs and QA department to fulfil their requirements.
9. To keep the facility all time ready for regulatory and customer audits.
10. Initiate, review LIMS error handling & prepare the investigation report.
11. Initiation and review of change control / discrepancy, Specification / STP, Test data sheet.
12. Conducting training related to analytical instrument, Document control systems, Specification / STP.
13. Review, approve the process/ cleaning validation request.
14. Preparation, review and revision of Specification / STP, Test data sheet.
15. Upload the Specification / STP, Test data sheet, SOP, protocol, report into DCS.
16. Co-ordination with QA, DQA, CQA, RA, ADL, CRD departments for revision and approval of Specification / STP, Test data sheet.
Alembic Pharmaceuticals
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