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.
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Quality Assurance Specialist in Ware employer: Advanced Resource Managers Ltd
At Advanced Resource Managers Ltd, we pride ourselves on being an excellent employer, offering a dynamic work culture that fosters collaboration and innovation. Our Suffolk location provides a unique opportunity to engage in significant infrastructure projects while benefiting from professional growth through continuous training and development. We value our employees by providing competitive benefits and a supportive environment that encourages leadership and impactful contributions to major initiatives.
Contact Details:
Advanced Resource Managers Ltd Recruitment Team
