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• Previous experience of GMP documentation reviews with strong attention to detail in Quality Assurance role.
• Good communication skills with the ability to build relationships and trust; and make decisions based on GMP principles.
• Ability to work under pressure in an environment where a range of issues will pull upon your time and where there are likely to be conflicting priorities.
• Previous involvement in Quality Deviations/Customer Complaints/Vendor Complaints, Change Controls and inspections/audits.
• Experience of Manufacturing and packaging of a range of pharmaceutical dosage forms including sterile products
• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
GlaxoSmithKline (GSK) is one of the world’s leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.
We are currently recruiting a QA Advisor to be based in Harlow, Essex, UK to join the Preclinical Quality Assurance Operations group within Research and Development based at Ware and Harlow, UK but also supporting other sites that fall within the department’s responsibilities.
The successful candidate will have a critical role in ensuring quality and compliance of Investigational Medicinal Products used worldwide. In addition the job holder will have the opportunity to further develop existing expertise and to gain experience within an R&D environment.
The successful candidate will be involved with a diverse range of activities including:
• Review and recommend release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP/GSK requirements.
• Assessment of Quality Deviations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.
• Provide advice and support to business partner areas relating to quality matters and process improvement.
Closing date for applications: Friday 20th October 2017.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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