
Assistant Manager Validation
3 days ago
Reporting to: Senior Manager Validation
Job Summary:
This role will be responsible for providing support to the Validation Review Board (VRB) and Validation Execution Team for Validation and Qualification activities related to Products, Processes, Cleaning, Computer Systems, Equipment, Utilities, and Facilities.
Major Responsibilities:
- Implementation and compliance with all the SOPs and EQD/AQR Policies and Procedures related to 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 a quarterly basis.
- Preparation of QA Checklist for Request for Capital Expenditures (RCEs), Quality and Regulatory Issues, and Action Plans as required.
Education/Knowledge & Experience:
Science Graduate/Master; preferably Pharm D.
4-5 years' experience in the same capacity.
Proficient in MS Office.
Analytical Skills.
An Equal Opportunity Employer. Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com.
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