Title:  Manager- Lead Investigation of UPD/OOS/OOT

Position:

Job Title:

Manager – Investigation Lead (OSD)

Job Grade:

Manager

Function:

Production

Sub-function:

Lead Investigation of UPD/OOS/OOT

Manager’s Job Title:

Skip Level Manager’s Title:

Function Head Title:

Location:

Halol-II Tablet Department

No. of Direct Reports (if any)

Areas of Responsibility

JOB DESCRIPTION:

1. He is accountable for COE (Centre of Excellence) related activities.
2. He is accountable for daily activity (as a Manager) :

• Overall responsible for production and packing activities related to Tablet, Soft Shell &Gel department.
• Responsible for the day to day production functions in production.

3. Establishing new procedures, maintaining and updating existing procedures in the Tablet, Soft Shell& Gel department.
4. To assist establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for follow established procedures, maintaining and updating existing procedures department.
5. Updation Approval and Execution of BMR, SOP, Protocol and other GMP documents.
6. Preparation of daily reports to production manager / superiors on day to day activities concerning the department.
7. Coordination with other departments like Administration, Warehouse, Quality Control, Quality Assurance, Quality Engineering, MIS and Engineering for related activities.
8. Responsible to co-maintain, coordinate for validation and GMP in all departments along with the Quality Assurance officer and to co- ordinate with Quality control department in matters relating to product quality.
9.  Train the subordinates and manpower to meet the organizational goals and achieve GMP compliance.
10. Optimization of resources namely men, material and machine in respective department.
11. Help the officers/ subordinates into standardize production activities to achieve better efficiency and product quality.     
12. Responsible for Calibration, Qualification and Validation activity of respective Equipment’s or Product.
13. Responsible for Production Planning, schedule, control and execution, E-log / Ample Logic Execution. Approval of Job Responsibility & Indent.
14. Responsible for investigation preparation and approval in trackwise.
15. Initiator, Review & approval in Track wise, Medhas Module, EDMS, SAP, LMS module access.
16. Responsible to perform the internal audit as auditor.
17. Responsible for preparation / review of Risk assessment for New / Existing product, Evaluation and Approval.
18. Responsible for Activity of Rejection / Reprocessing based on Corrective actions of Investigation. Destruction note review and approval.
19. Responsible for Effective Compliance of Regulatory Observation, its Report documentation & Approval.
20. Procurement of machineries, change parts, spares and material required in respective department.
21. Any other job assigned by the superior.
22. Mr. Prerak Shah is also responsible for carrying out any other responsibilities assigned by superior from time to time orally or in writing.

Travel Estimate

NA

Job Requirements

Educational Qualification

B Pharmacy/M Pharmacy

Specific Certification

Basic Statistic or 6 sigma Certified

Skills

Good Writing Skill on UPD/OOS/OOT

Experience

10-16 years