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PSQA Document and Records Management

2.00 to 5.00 Years   Chennai   30 Sep, 2019
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

  • Monitor and review issuance, archival and reconciliation activities in day-to-day basis and ensure document control as per regulatory standards and company standards.
  • Co-ordinate with business-line personnel for archiving and reconciliation of the issued documents in timely manner.
  • Ensure Archival Index is updated and documents are stored at appropriate location in record center.
  • Tracking and coordinate the biannual reversion of SOPs and supporting to upload the SOPs in SAP DMS.
  • Ensure appropriate archival / retrieval for the paper-based documents generated.
  • Provide support during internal and external audits.
  • Responsible to provide supporting data for QRM meetings as scheduled.
  • Provide support to inspection readiness and GMP walk-throughs for compliance activities.
  • Performs procedural administration activities within the Global Documentation Management System.
  • Partners with SOP authors to develop procedures and appropriate implementation plans for the management of physical and electronic documentation.
  • Partners with PharmSci business lines in the development, implementation and management of their procedures, documentation and records.
  • Supports the management of Active libraries and other documentation systems (e.g. Document Long Term Storage) for PharmSci to ensure adequate control of physical and electronic records, including logbook issuance and reconciliation.
  • Partners with the Enterprise Records and Information Management (eRIM) team to ensure alignment with Pfizer record retention policies and legal holds.
  • Provides Global Document Management System (GDMS) Subject Matter Expertise to global and site customers
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Keyskills :
subjectmatterexpertise documentmanagementsystem documentcontrol managementsystem documentmanagement qualemploymentopp tunity

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