Officer / Executive

Honour Lab Limited; Anakapalli; On-site; INR 300,000 - 600,000; Full time

Job summary

Honour Lab Limited in Andhra Pradesh is seeking a QA Documentation & Compliance Associate to ensure GMP/GLP adherence, manage QMS, document control, and product release processes across departments.

The role includes SOP preparation, change controls, CAPAs, audits, and training coordination, with careful data review of LIMS and related systems to support quality objectives.

Strong attention to detail and collaboration with QA, Production and QAD teams are essential for success in this role.

Responsibilities

• GMP/GLP/compliance adherence and document control across departments.
• Prepare, review and issue SOPs, forms, and QMS documents.
• Review and release of QA data, CAPAs, change controls, and incident reports.
• Coordinate training programs (GMP and job training) and audits.
• Oversee QMS, LIMS, WMPS, QR code related activities and trend reports.

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.