Posted in Software 30+ days ago.
This job brought to you by eQuest
Location: King of Prussia, Pennsylvania
Position Title: Operational QA Advisor
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: 2 years
Required Education: Bachelors
Travel Required: 0%
An opportunity has arisen to join External QA in the US as an Advisor. External QA is part of Preclinical Quality Assurance in Global Quality and Compliance that provides QA support to PDS 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 ongoing at 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.
Key responsibilities include:
Review of documentation (batch and analytical records) and recommend release 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 follow up on the implementation of those recommendations.
Initiation and maintenance of quality agreements with third party suppliers & contractors
Assist in the collection and compilation of Supplier performance data and metrics
Provide advice and support to business partner areas relating to quality matters and process improvement.
• Bachelor’s degree in a science discipline (preferred) or equivalent combination of specialized training and relevant work experience.
• Previous experience of GMP documentation reviews with strong attention to detail
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age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
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