Quality Assurance Specialist in Ware, Hertfordshire

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.