Quality Assurance Specialist

Are you an experienced Quality Assurance Specialist with a background in the review and approval of GMP documentation? If so, this role could be for you!

Our leading CRO client is recruiting for a QA Specialist to be based at their clients facility in Hertfordshire.

The successful candidate will have a crucial role in ensuring quality and compliance of investigational medicinal products used worldwide.

This position is offered on a 12 month contract basis initially, inside IR35, working 37 hours per week.

Responsibilities:

• Serve as a Batch Release Officer for the review and recommended release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products.
• Assessment of Quality QMS Records (e.g. deviations and third party or internal complaints) and make recommendations for corrective and preventative actions.
• Follow up on the implementation of those recommendations.
• Review and Approve GMP documentation, which may include Packaging Specifications, Quality Agreement, Change Controls and other controlled documents
• Provide advice and support to business partner areas relating to quality matters and process improvement.
• Develop and incorporate effective processes and procedures in Quality R&D Packaging Third Party group and may contribute to business processes and procedures outside of quality
• Support Packaging Third Party Qualification
• Participate in or lead improvement initiatives

Education and Experience:

• Bachelor''s degree or equivalent work experience such as 5+ years in similar position
• Experience of QA review of GMP Manufacturing / Packaging Documentation / laboratory records of pharmaceutical dosage forms which may include sterile products and/or review and approval of GMP documentation within a Quality Assurance / Quality Control role.
• Experience of knowledge of GMP principles and being a decision maker using this knowledge,
• Experience leading or participating in QMS activities (e.g. Quality Deviations, third party/Internal Complaints, Change Controls and inspections/audits and root causing).
• Experience working in high pressure environments where there are likely to be conflicting priorities.
• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
• Strong attention to detail.
• Good communication skills with the ability to build relationships and trust.

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission. Where the role is marked as Outside IR35 in the advertisement this is subject to receipt of a final Status Determination Statement from the end Client and may be subject to change.