Senior Advisor External QA
- Scientific degree or equivalent.
- Previous experience of GMP documentation reviews with strong attention to detail.
- Good communication skills with the ability to build relationships and trust, and make decision 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.
- Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
- Demonstrated ability to function effectively as part of a team; to communicate effectively with all levels of management and to negotiate persuasively.
- Demonstrated ability to work independently; to set priorities, meet deadlines and handle a high volume of work.
- Demonstrated ability of third party auditing of starting materials, API and finished product suppliers and contractors.
- A broad scientific background with experience in Pharmaceutical Research and Development or Manufacturing operations or previous experience in GMP Compliance and/or Quality Assurance.
- Experience of third party auditing of starting materials, API and finished product suppliers and contractors.
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.
An opportunity has arisen to join External QA in the UK as a Senior Advisor. External QA is part of Preclinical Quality Assurance in Global Quality Assurance that provides QA support to PDS, Dermatology Unit and GSK's third party partners. External QA is a global team based in UK, US & Shanghai. The role will work closely with and assist all the External QA Managers in their support of the activities related to third parties globally. 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:
- Assessment by Audit (on site and remote) of third party suppliers to GSK as part of the PCQA auditor pool.
- Review of documentation (batch and analytical records) and recommend release for Intermediates, API and 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 follow up on the implementation of those recommendations.
- Initiation and maintenance of quality agreements with third party suppliers & contractors including management of the review of quality agreements
- Assist in the support of oversight of analytical laboratories including the review of technical agreements.
- Assist in scheduling assessments for new/existing suppliers/contractors and associated Vendor Management activities.
- Assist in the tracking and chasing of CAPAs associated with third party assessments.
- Provide advice and support to business partner areas relating to quality matters and process improvement.
Closing date for applications: Monday 18th September 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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