Date PostedDecember 13, 2022
Location (State / UT)
Expiration dateMay 15, 2024
Experience13 Years, 17 Years
Desired QualificationBachelor Degree, Master’s Degree
1. To handle QMS activity Unplanned Deviation (UPD), Out of specification (OOS)/ Out of trend (OOT), Market complaint investigations, and its related activities.
2. To obtain reviews from other departments who are stakeholders in the deviation outcome and investigation process for a timely closing of Investigation reports and its documentation of the Oral Solid department.
3. To perform Immediate Brainstorming, in in-order to outline further actions with a target completion date (TCD).
4. To maintain a dashboard for pending cross-functional investigations with TCD and the way forward.
5. To escalate the investigation to Site Quality Leadership if the root cause of the investigation cannot be identified.
6. To participate in weekly meetings with Blockheads and fortnight meetings with Site Leadership Team for the way forward on pending cross-functional investigations.
7. To participate in Site Investigation Review Board meetings:
a. To provide details of in-progress and closed investigations.
b. To discuss the issue, the report content, appropriateness of the identified root cause, and assess the product, and material disposition decision.
8. To analyze the deviation trends and conclusions for further improvement at regularly scheduled management review meetings.
9. To train the shop floor team about reported deviation, investigation, and recommended CAPA to avoid recurrence.
10. Responsible for completion of CAPA and related activities in the Trackwise system within the due period.
11. Trending of product CQAs to understand early indications for shifting/drifting of trend. Based on an understanding of trend initiation of corrective action with the support of the cross-functional team.
12. Trending of Batch rejections to identify no repetitive failures if any with similar cause/product and initiation of actions with the cross-functional team.
13. Preparation and Review of the following documents:
- Unplanned Deviation and Investigation reports, Addendum reports, compliance, and closure reports.
- CAPA plans and CAPA effectiveness check reports.
- Protocols & Reports.
- Internal Quality Audit / Regulatory Quality Audit Compliance and closure.
- Following cGMP documents but not limited to,
Sequential Log, Checklist, Instrument Inward-Deletion Slips, Labels, In-process / Finished Product Test Requisitions, Data Reports, Bulk quarantine / Staging room In-Out records, etc.
- Change control, Standard Operating Procedure.
- Other quality documents including amendments.
14. Make daily reports to superiors on day-to-day activities concerning the department.
15. Coordination with other departments like Administration, Warehouse, Quality Control, Quality Assurance, Quality Engineering, MIS, and Engineering for related activities.
16. To assist in establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for following established / new procedures, maintaining and updating existing procedures in the department.
17. Training the subordinates and manpower to meet the organizational goals and achieve GMP compliance.
18. Responsible for Internal Quality Audit / Regulatory Quality Audit Compliance.
19. Help the officers/subordinates into standardizing production activities to achieve better efficiency and product quality.
Education: M. Pharm.
Experience: 13-18 Years.