QA Document Controller for Pharma Candidates @ GSK

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GSK

GSK is one of the world’s leading research based pharmaceutical and healthcare companies. GSK will be investing up to INR 1000 Crores (£100m) in a new ‘state of the art’ pharmaceutical factory in Vemgal (45 KMs away from main city), Bengaluru. The factory will initially supply a range of solid dose form products. After completion of the project, the factory will produce more than 9 Billions tablets and capsules per year, supplying the Indian market with product, with production ramp-up through 2017. The factory is being built to the highest international standards using the latest process technology.

Job Title  QA Document Controller

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No. of Posts 1

Job Description:

JOB PURPOSE

  • To handle the Project level & Operational documentation management.

KEY RESPONSIBILITIES

  • Management of GMP documents, SOPs, SWIs, record templates e.g.
  • Proforma and logbooks using CDMS.
  • Documentation Control will manage GMP document archive.
  • Responsible for establishing a records retention schedule.
  • Responsible for the delivering and promoting a culture of maintaining and improving the performance of
  • Safety, Quality, Cost and Customer Service
  • Use gembas to identify abnormalities from the standard and to get them fixed, fast. Escalate if appropriate through the tiered accountability process.

Qualifications

  • 6+ years experience in Pharmaceutical Plant handling document management system
  • Knowledge on QA documents.
  • Knowledge of QMS and Regulatory regulations.
  • Hands on document management and archival.
  • Able to provide and retrieve documents on time and support audits
  • Support the entire cross functional teams to review and approve documents in Controlled Document Management System.

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