Job Description

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: * He is accountable for COE (Centre of Excellence) related activities.

• 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.
• Establishing new procedures, maintaining and updating existing procedures in the Tablet, Soft Shell& Gel department.
• To assist establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for follow established procedures, maintaining and updating existing procedures department.
• Updation Approval and Execution of BMR, SOP, Protocol and other GMP documents.
• Preparation of daily reports to production manager / superiors on day to day activities concerning the department.
• Coordination with other departments like Administration, Warehouse, Quality Control, Quality Assurance, Quality Engineering, MIS and Engineering for related activities.
• 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.
• Train the subordinates and manpower to meet the organizational goals and achieve GMP compliance.
• Optimization of resources namely men, material and machine in respective department.
• Help the officers/ subordinates into standardize production activities to achieve better efficiency and product quality.
• Responsible for Calibration, Qualification and Validation activity of respective Equipment\'s or Product.
• Responsible for Production Planning, schedule, control and execution, E-log / Ample Logic Execution. Approval of Job Responsibility & Indent.
• Responsible for investigation preparation and approval in trackwise.
• Initiator, Review & approval in Track wise, Medhas Module, EDMS, SAP, LMS module access.
• Responsible to perform the internal audit as auditor.
• Responsible for preparation / review of Risk assessment for New / Existing product, Evaluation and Approval.
• Responsible for Activity of Rejection / Reprocessing based on Corrective actions of Investigation. Destruction note review and approval.
• Responsible for Effective Compliance of Regulatory Observation, its Report documentation & Approval.
• Procurement of machineries, change parts, spares and material required in respective department.
• Any other job assigned by the superior.
• 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