Executive

Honour Lab

Anakapalli

On-site

INR 450,000 - 750,000

Full time

8 days ago
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Job summary

Honour Lab is seeking a QA/QC professional to uphold GMP/GLP and safety norms while ensuring strict adherence to company policies. The role involves distributing SOPs, reviewing data in LIMS, and coordinating QMS-driven activities across departments.

You will review production records, manage change controls, incident handling, and validation/quality risk reports, while supporting EHS and QAD-related tasks. Strong documentation discipline is essential.

Qualifications

  • Familiarity with GMP, GLP, and safety norms. Ability to adhere to company policies.

Responsibilities

  • 1. Follow GMP, GLP, safety norms and company policy. 2. Distribute SOPs, forms, STPs, MFS and protocols. 3. Control archives and review printed data via LIMS. 4. Review BPRs from production. 5. Issue/receive documents to all departments; prepare SOPs, annexures & indices.
  • 6. Check records per QAD release checklist and release products after QAD approval. 7. Prepare/review annual product quality review reports and trending. 8. Prepare/review process capability reports. 9. Issue product labels and QA release labels. 10. Line clearance during product changeovers. 11. Handle QMS, WMPS, LIMS and QR code activities. 12. Review/assign QMS numbering for events (OOS, OOT, complaints, CAPA, etc.). 13. Notify relevant team leaders on incidents and initiate events. 14. Initiate/review/close change controls, incidents, CAPA, QR code errors in QMS. 15. Prepare/review QMS trending, MRM and internal audits. 16. Support EHS and QAD activities. 17. Prepare/review stationary activities; prepare/review quality risk protocols. 18. Coordinate GMP & job training programs; track schedules. 19. Attend GMP & job training; prepare/review CEBIT & DEI-IT protocols & reports. 20. Initiate/review/approve stability protocols and reports. 21. Prepare/review validation protocols & repor

Job description

1.TO follow the GMP, GLP, Safety norms and adhere to company's policy. Issuing and receiving of documents to all departments.

2. . Document distribution of SOPs, Forms, STPs and MFS and Protocols. 3. Controlling Of Archives & Review Of Printed raw data generated through the LIMS. Rewiew the in process, Intermediate, Finished analytical data.

4.Review of the filled BPRs received from the production.

5.Issuing and receiving of the documents/controlled copies to all departments Preparation of Department related SOPS, Annexures & Index's.

6. Checking of all records as per QAD Release checklist and release the product after getting the approval from QAD Head / his designee Preparation and review of Annual product quality review reports and trending.

7. Preparation and review Of Process capability reports.

8. Issuing Of Product labels and QA Release labels.

9. Line clearance activity during product changeover cleaning.

10. Handling ofQMS, WMPS, LIMS and QR Code related job activities.

11. Review and allotting the numbering system for QMS events such as OOS, OOT, Customer Complaints, Returned Goods, LIR and AER, LER, Incidents, CAPAs change controls etc.

12. After identifying the incidents inform to respective team leader / department [IOD and initiate the event with assistance Of team leader

13. Responsible for initiate, review and closure of change controls, Incidents, CAPA, QR code errors through QMS spectrum. Ensure timely completion or action items, effectiveness and closure of QMS events as per target timelines

14. Preparation and review of QMS trending's, MRM and Internal audit related activity.

15. Supporting EHS and QAD related activites.

16. Preparation and review Of Stationary activity. Preparation and review Of Quality Risk assessment protocols and reports.

17. Coordinating for training programs (GMP & Job training) as per the schedules.

18. Attending Training programs (GMP & Job training) as per the schedules Preparation and review of CEBIT & DEI-IT protocols & Reports. 19. Initiation, review and approval of Stability protocols and Stability reports.

20. Preparation and review of Validation protocols & Reports.

21. TO perform any Other activity assigned by the Head-QAD.

22. Reponing to QAD GIVI/his designee.


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