Advertised on 2-6-11.
GlaxoSmithKline is a world leading research-based pharmaceutical company with a powerful combination of skills and resources that provides a platform for delivering strong growth in today's rapidly changing healthcare environment. We are strengthening our quest to help people worldwide do more, feel better and live longer. We invite dynamic individuals, who want a challenging career in the biomedical sciences industry to join us.
This role will assist in managing the quality related aspects of our business partner TPs with respect to their Hub operations.
Quality compliance of Third Party Operations
- Monitors Quality Performance of TP operations to ensure AP S&D Hub operations meet GSK standards, and the requirements of our QMS
- Provides routine quality performance reports to AP S&D management team
- Approves local SOPs, ensuring compliance with GSK global procedures and undertakes periodic quality assessments/audits of TPs to provide ongoing quality assurance of operations
Compliance with AP S&D Hub QMS Policies
- Maintains risk register with quality matters and ensures that any changes within the operation are appropriately validated and documented using Company recognised systems of approval
- Evaluates and approves CAPAs and non-conformance reports. Escalates critical quality issues with high business impact and performs periodic review of Quality data
- Executes the validation master plan and ensures it is kept current and executed accurately
- Maintains TTS documents, Product Quality and redressing specifications as required.
Product Incident Management
- Ensure Quality Critical Incidents are escalated to AP management team and mangaged according to GSK policies.
- Works effectively with the Supply sites quality team to coordinate and manage the investigation and effective communication with site/market and Global QA .
- Ensures TPs operation is in a state of inspection readines, draft responses and Corrective Action Plans are prepared after a Regulatory/Corporate Inspection and all the actions are completed within the identified timelines.
- Act as a key point of contact for QA information/document provision to a manufacturing site or market
- Assists the QA manager to ensure audit and self-inspection programmes are planned, implemented and any observations are closed in compliance with regulatory expectations.
- Performs quality audits of TP operations to ensure they continue to meet GSK standards for warehouse, distribution and relabelling activities as relevant
- Performs GMP training for all AP S&D Hub staff
- Manage and maintain records for Quality training programme including QMS and GQMPs/GQGs as relevant
- Degree in Science or Engineering
- Quality experience within the pharmaceutical industry and experience of application of quality systems on Commercial operations is highly preferred
- At least 3 years Quality experience in a Consumer Healthcare, Pharmaceutical or OTC medicines storage and distribution operation
- Good knowledge of local regulations, cGMPs and familiarity with local and international regulations, guidelines and Operational Excellence,
- Good understanding of validation principles in product storage and distribution, GDP and supply chain operations
- Ablility to influence and negotiate with key contacts, both internal and external to GSK
- Possess multi-tasking and good problem-solving skills.
Interested applicants, please send your updated resume in MS Word to SG Recruitment-HRSS OAX83566@gsk.com by 13 June 2011.
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Company Registration No: 1991