Assistant Manager Validation
Abbott
Date: 1 week ago
City: Karachi
Contract type: Full time
Position: Assistant Manager Validation
Reporting to: Senior Manager Validation
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Pakistan
Job Summary
This role will be responsible for providing support to Validation Review Board (VRB) and Validation Execution Team for Validation and Qualification activities related with Products, Processes, Cleaning, Computer System, Equipment, Utilities, Facilities.
Major Responsibilities
Reporting to: Senior Manager Validation
Division: Established Pharmaceutical Division - Operation
Location: Karachi -Pakistan
Job Summary
This role will be responsible for providing support to Validation Review Board (VRB) and Validation Execution Team for Validation and Qualification activities related with Products, Processes, Cleaning, Computer System, Equipment, Utilities, Facilities.
Major Responsibilities
- Implementation and compliance of all the SOPs and EQD/AQR Policies and Procedures related with Validation/Qualification
- Preparation of Validation Master Plan (VMP) & Site Validation Master Plan (SVMP), its implementation and updating at least annually
- Preparation, execution and approval of Validation/Qualification protocols and reports
- Preparation of Continuous Process Verification Protocol and Reports
- Validation/Qualification studies other than the routine schedule and Continuous Improvement Projects, new products, stability
- Update Validation Metrics on quarterly basis
- Preparation of QA Checklist for Request for Capital Expenditures (RCEs), Quality and Regulatory Issues and Action Plans as per required
- Science Graduate/Master; preferably Pharm D
- 4-5 years’ experience in the same capacity
- Proficient in MS Office
- Analytical Skills
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