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Deputy Manager


Chennai, TN 600006
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Job Details

1. To perform Quality oversight towards validation or qualification tests of new or existing equipment, facility or software in accordance with guideline or protocol.

2. Review validation master plans, process flow diagrams, test cases, or standard operating procedures. Review validation or performance qualification protocols for new or modified manufacturing equipments, systems, facility or equipment.

3. Analyse validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems and compliance with regulatory requirement.

4. Review detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.

5. Assist in training equipment operators or other staff on validation protocols and standard operating procedures.

6. Review validation and compliance documentation, such as engineering change notices, schematics, or protocols.

7. Handling of Deviation, Change Control & related CAPA

8. Managing the Review and approval activities of all qualification (URS, SLIA, CLIA, DQ, IQ, OQ & PQ) & validation project plans, site master plans, protocols, project plans, engineering assessments and final reports.

9.. Provide regulatory guide line based technical support for validation, calibrations and equipment control programs. Participate in and/or lead risk assessment activities.

10.Established and implemented a Risk Based Validation Program including a Facility Validation Master Plan, 21 CFR Part 11 Assessment & Remediation Policy, Periodic Validation Review / Revalidation SOP for Equipment, Utilities, QC Laboratory, and Computerized Systems. 11. Evaluated change control submissions for validation impact as a member of the Change Control Committee. Introduced new tools for 21 CFR Part 11, validation determination, and risk-based assessments. Promoting Process Improvements.

12. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies;

13. Contributes to team effort by accomplishing related results as needed. Developing Standards and Supports Innovations.

14..Demonstrate confidence during difficult decision-making and influence business partners to ensure acceptable quality outcomes

15. Attract, retain and proactively develop a pipeline of key talent through coaching and training,

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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