Title:  Manager - 2 OSD Investigation

Designation - Sr. Manager -2

Qualification - B Pharmacy/M Pharmacy

Experience - 12-20 years 

JOB DESCRIPTION:

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 timely closing of Investigation reports and its documentation of Oral Solid department.
3. To perform Immediate Brainstorming, in-order to outline further actions with target completion date (TCD).
4. To maintain dashboard for pending cross functional investigations with TCD and 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 meeting with Block heads and fortnight meeting with Site Leadership Team for way forward on pending cross functional investigations.
7. To participate in Site Investigation Review Board meetings:
   1. To provide details of in-progress and closed investigations.
   2. To discuss the issue, the report content, appropriateness of the identified root cause, 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 Trackwise system within due period.
11. Trending of product CQA’s to understand early indications for shifting/drifting of trend. Based on understanding of trend initiation of corrective action with support of cross functional team.
12. Trending of Batch rejections to identify no repetitive failures if any with similar cause/product and initiation of actions with cross functional team.
13. Preparation and Review of following documents:

• Unplanned Deviation and Investigation report, 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 establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for follow 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 standardize production activities to achieve better efficiency and product quality.