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Pfizer is Looking for a Competent Professional to be responsible for the entire Documentation Control at the Vizag site.
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Designation: QA Documentation Control Lead
Location: Vizag, Andhra Pradesh
Job Description:
Documentation Control
- Issuance, retrieval, storage, archival, and disposal of Documents or Records.
- Control the Document Life cycle process at the Vizag site and manage the QA Documentation Control team at the Vizag site.
- Management of Master Documents using the Pfizer Management Document System (PDOCS).
- Ensure availability of necessary procedures for the management of documents at the site (for e.g. creation of procedure, retention of documents, Good documentation practices, control and issuance of artworks)
- Manage and monitor the issuance of all GMP documents including batch manufacturing and testing records.
- Manage archival of all GMP documents and retrieval and issue as required for reference purposes.
- Develop and implement tools and guidelines that will improve documentation systems.
- Review and approve metrics for Documentation and associated events and CAPA’s.
- Identify the development needs of documentation staff and provide the necessary coaching and mentoring for their development
- Support internal audits and inspections from External/ Regulatory agencies.
- Review and approve completion of CAPA’s, Event relevant to documentation department, and its effectiveness.
- Provide change impact assessment related to documents.
- Support the activities related to Quality Systems Team.
- Adherence to Safety Procedure, GMP & GDP practices by Team and Self
Records Management at Site
- Subject Matter Expert and Point of contact for Management of Documents/ Records at the Vizag site.
- Establish Documents/ Records and Digital storage media (DSM) management at the site
- Ensure Compliance with Enterprise Records Retention Schedule (ERRS) maintained by the enterprise records and Information Management (eRIM) group
- Manage and monitor the issuance and retrieval of all executed/ archived GMP documents/ records
- Overall management of Document storage areas
- Ensure timely issuance of retrieval document/ records for Regulatory inspections/ audits
- Developing, Maintaining, Verifying and Evaluating of existing systems
Offsite Records Management
- Subject Matter Expert and Point of contact for office site record management at Vizag site
- Monitor the offsite record management activities
Digitalization of Records
- Ensure proper scanning of Documents/ Records and make sure all the archived records are digitized into an appropriate electronic document management system.
- Point of contact for electronic Documents/ Records management application.
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