Team Member Eqa

1 week 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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