Team Member Eqa

7 months ago

Andhra Pradesh, India Dr Reddy's Laboratories Limited Full time

Ensure the compliance with corporate policies (Quality, Safety, COBE etc...)
- Review and approval all validation protocols and reports with respect to URS/DQ/IQ/OQ/ PQ for facility, area, equipment and utilities.
- Review and approval of layouts.
- Review and approval qualification and Requalification document of the followings:

- All manufacturing and packing equipment
- Water system (Purified water, Purified and WFI generation & distribution system)
- HVAC, EMS and Building management system.
- Utilities like compressed air, Nitrogen system, Steam generator, Chiller, Cooling towers and pure steam generation and distribution system.
- Computer system validation, software validation.
- Participate in validation activities to ensure compliance with approved protocol and VMP.
- Preparation, review and approval and revision of Validation master plan.
- Preparation, Review, approval and implementation of SOP related to Engineering and Quality assurance.
- Review and approval of all master schedules related to calibration, PMP, FM etc.,
- Review and approval of all trends related to water and environmental monitoring and etc.
- Verification of Vendors / Third party contract agreement those are required for performing calibration of specific instruments / Equipment on / off site and perform audits to service providers related to Engineering dept..
- Coordinate and participate in preparation of risk assessment for all new equipment / Facility / Systems / utilities / process.
- Investigation of event/Incidents and corrective and preventive action identification during validation and implementation of the same.
- Review of M1 and M2 notification on timely.
- Review of backup and audit trials.
- Evaluation, review, approval and closure of Change controls / CA-PA.
- Support and participate in all customer and regulatory audits.
- Ensure cGMP (current Good Manufacturing Practices) and implementation of standard Operating Procedures.
- To follow Safety, Health and Environmental procedures and practices.
- Any other work assigned by upward staff.

**Qualifications**
B Pharm, M Pharm, BSc., MSc.
**Additional Information**
Soft skills & computer proficient

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