Sr Manager QC

1 week ago

Guwahati, Assam, India UNO SOURCE Full time ₹ 20,00,000 - ₹ 25,00,000 per year

  1. Working in a LIMS as per access level in laboratory information management system (LIMS). Access in LIMS through password.

  2. Review and approval of LIMS master test plan for Raw Materials, Packaging materials, In-process samples, Finished products, Stability study samples and working standard materials

  3. To ensure sampling activity of raw material and packaging material.

  4. To approve or reject the Raw Materials, Packaging materials, In-process samples, Finished products, Stability study samples and working standard materials in LIMS. Approval of certificate of analysis for the same.

  5. To review and approval of specifications, sampling instructions, test methods and other Quality Control procedures in LIMS.

  6. Review and approval of artwork.

  7. To ensure maintenance, storage, usage and destruction of standards, reagents, columns.

  8. To ensure the timely transfer and verification of analytical method from analytical development laboratory and other laboratory.

  9. To ensure retesting of raw materials and its approval.

  10. To review process validation and cleaning validation protocols and reports.

  11. To review and approval of stability protocols and reports.

  12. To review, approve and monitor QMS activities like Incidence, deviation, Corrective Action and Preventive action (CAPA), change control (CC) and Non conformance report (NCR).

  13. Investigation of failures, out of specification (OOS) and out of trend (OOT) results.

  14. To ensure that the compliance of the Microbiology department activities.

  15. To ensure the calibration and qualification of all QC instruments/equipments as per schedule.

  16. To ensure that the required initial and continuing training of QC department personnel is carried out and adapted according to need and as per schedule.

  17. To review validation protocols and reports for software's in the department.

  18. To review product quality review (PQR) reports.

  19. Handling of Internal and External audits and its compliance.

  20. Evaluate the laboratory needs/requirements (i.e. New instrument/Equipments, sufficient manpower, appropriate working environment etc.) and arrange the same for smooth functioning of the activities.

  21. Participation of cross functional team (CFT) member for self-inspections, market complaint, product recall, return goods and audit compliance (as applicable).

  22. To ensure the integrity of all data generated either manually or electronically.

  23. Control sample observation.

  24. Review of Raw Material, In process material, Final Products, Packaging and Stability specification.

Job Types: Full-time, Permanent

Pay: ₹2,000, ₹2,500,000.00 per year

Benefits:

  • Health insurance
  • Provident Fund

Work Location: In person

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