GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post: Manager OSD (Pharmacist)
Job Description
The purpose of this job is to:
- Be the named person accountable for the 'well being' of a OSD product or product family. ‘Well-being’ encompasses hands-on knowledge of the equipment, manufacturing process & the product critical quality attributes (CQAs) and critical process parameters (CPPs).
- Manage technology transfer for respective products from R&D into GMS and subsequent transfers to other sites.
- Influence the manufacturing process / analytical process / pack / device and associated specifications throughout the product lifecycle.
- Support standardisation of manufacturing and analytical technology across sites engaged in manufacture of common dose forms
Candidate Profile
- Understands the key interactions between raw materials and equipment during dosage form manufacture and the resulting transformations
- Ensures the critical process parameters (CPPs) of the dosage form or API are known, understood, controlled and verified
- Ensures the critical quality attributes (CQAs) of the dosage form or API are known, understood, controlled and verified
- Coordinates the Technical Risk Assessments in support of Design for Manufacture and Change Management
- Trends product performance and acts on process drift (including stability)
- Knowledge of Global GMP and Regulatory requirements
- Understanding of QMS (traditional) and mandated documents supporting the NPI process
- Understanding of future state Quality Systems (e.g. validation lifecycle and real time release)
- Knowledge of compliance requirements e.g. facility registration, inspections, annual reports, field alerts and recalls
- Knowledge of In-vitro testing (analytical), traditional and future & automation
- Excellent communication skills both verbal and written
- Provides leadership (directly or indirectly) to a relevantly skilled technical team on all technical aspects of that API/product manufacture.
- Works with the end-to-end supply chain to optmise the technical performance of allocated API/products within manufacturing
- Liaises with other Product Owners, including counterparts in Primary/Secondary, to share and capture best practices (local/regional/global as required)
Additional Information:
Experience: 3-5 years
Qualification: B. Pharm/ M. Pharm
Location: Mumbai, Nashik, Bangalore
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacist
End Date: 15th August, 2015
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