Dr Reddy’s Hiring Pharma For Lead Qualifications CoE Role – Apply Now
Lead Qualifications CoE – Sterile
Location: Visakhapatnam Rural Mandal, India
Job Description
- Qualification of new equipment (Manufacturing, Packaging, WH, Pilot Production)
- Review of the FAT (Factory Assessment Test)/Commissioning with the engineering department as per pre-approved documents
- Evaluating and ensuring availability of the related drawings, manuals & test report required for the preparation of the qualification document
- Attending to all the review points given by CFT for the approval of the qualification document
- Coordinating with the cross-functional team to ensure/guide for installation, operational & performance qualification of the new equipment in the sterile vertical
Responsibilities:
- Participation in QRA
- Preparation of Qualification document based on approved URS/DQ/Approved Technical documents
- Facilitation of protocol approval with various CFTs and QA
- Plan and ensure execution of Qualification activities as per pre-approved protocol
- Addressing the gaps/deviations found during qualification activity with the vendor in coordination with the user and other CFTs
- Compilation of the test results of the executed qualification document
- Addressing the review points (if any) for closure of qualification document
Periodic Revalidation of Equipment (Manufacturing & Packaging):
- Preparation of revalidation document as per regulatory guidelines/In-house SOP
- Facilitation of approval of the document by the plant QA and CFTs
- Execution of the activity along with the user & other CFTs
- Compilation of the test result of revalidation activity
- Certification of the executed revalidation document by the plant QA
- Addressing/rectifying the deviations observed during revalidation with the user & other CFTs
Revalidation of Equipment Related to CRN (Change Request Note), MMR’s (Major Maintenance Request):
- Preparation of revalidation document as per the extent and criticality of change/maintenance incurred, following regulatory guidelines
- Support in performing QRA
- Approval of the document by the plant QA and CFTs
- Execution of the activity along with the user & other CFTs (Production, Engineering, Project, QA, Pilot Production)
- Compilation of the test result of revalidation activity
- Certification of the executed revalidation document by the plant QA
- Addressing the review points (if any) given by the plant QA
Qualification of Utilities like HVAC Systems, Water System, Compressed Air System:
- Facilitate FAT/Commissioning with the engineering department as per pre-approved documents
- Ensuring availability of the related drawings, manuals & test report required for the preparation of the qualification document
- Attending to all the review points given by CFT for the approval of the qualification document
- Coordinating with the cross-functional team to complete the installation, operational & performance qualification of the new equipment
Qualification of Facility Required for Manufacturing & Packaging of Sterile:
- Ensuring availability of the related drawings/design documents for the preparation of the qualification document
- Participate in risk assessment activity
- Attending to all the review points given by CFT for the approval of the qualification document
- Coordinating with the cross-functional team & vendor/project team to complete the qualification activity
- Addressing the deviations found during the qualification activity of the facility with the vendor in coordination with the projects and other CFTs
- Compilation of the test results of the executed qualification document
- Addressing the review points (if any) for closure of qualification document
Qualifications: B. Pharma/M. Pharma
Apply Now: Click here to apply
Keywords: Lead Qualifications CoE, Sterile, Dr. Reddy’s Laboratories, Pharmaceutical Company, Qualification Document, Commissioning, Revalidation, Facility Qualification. Dr Reddy’s Hiring Pharma For Lead Qualifications CoE Role – Apply Now. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
