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:Â Â Â QA Document Controller
No. of Posts:Â Â 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:Â
- 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.
