HomeHead/VP/CEO/President/GMQA Documentation Control Lead | Pfizer India | Vizag

QA Documentation Control Lead | Pfizer India | Vizag


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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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