GlaxoSmithKline Pharmaceuticals Limited
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.
GSK intends to create an environment where development of staff is key, where people delight in where they work and are inspired to deliver their best. A modern way of working will be created where people are valued for the contribution they make and where their career aspirations can be met.
This is an exciting development for GSK and the new factory at Vemgal aims to be recognized as a ‘benchmark’ operation.
To know more about our organization please login to www.gsk.com, www.gsk-india.com
Job Title: Officer Production(granulation & Blending) & Packing Officers
Experience: 3 – 5 yrs
Location : Bengaluru
Job Description:
JOB PURPOSE:
To ensure GMP compliance on the production shop floor on day to day basis from Operational Quality point of view through GMP rounds, documentation review. Responsible for Batch release. To act as first contact point for any Quality issues in area of operation.
KEY RESPONSIBILITIES
- Review of batch manufacturing and packaging records
- Support to other site areas e.g. QC / engineering / Logistics
- Managing of deviations and participating in RCA.
- Coaching and mentoring operations staff.
- To ensure release of bulk and finished products, meeting the statutory and QMS requirements, to market.
- To ensure that the activities on shop floor are in compliance with regulatory and QMS requirements.
- Review of Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOP.
- To complete the QMS training in time and ensure the compliance with QMS in area of operation.
- To support Level-2 Audits and conduct Self Inspection. To ensure compliance to all audit observations in a time bound manner.
- Handling of M-ERP System related to batch release and other QA transactions.
- Review of SOPs and ensure SOPs for area under control are valid and meets all regulatory and QMS requirements
- Carrying out verification of area documentation like batch records, log books, status labeling etc.
- Carry out in process check randomly in area of operation & document it.
- Routine GEMBA and ensures timely closure of GEMBA observations.
Qualifications: Looking for candidates with Bachelors in Pharmacy with 3-5 years of experience in Inprocess quality assurance in the manufacturing of tablets and capsules from a reputed pharma company.
