Role Title: Quality Assurance Co-ordinator Duration: 8 months (possible extension) Location: Harlow Rate: £23.64 per Hour – PAYE FT
Role purpose / summary
An opportunity has arisen for a QA Coordinator to join the Clinical Supply Chain Quality Assurance Operations group within Research and Development based at Harlow, UK.
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 develop expertise and to gain experience within an R&D environment.
In this role you will:
- Review GMP Manufacturing and/or Packaging Documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP requirements.
- Provide advice and support to business partner areas relating to quality matters and process improvement.
- Review and assessment of Temperature excursions for IMP shipments.
- Act as a Customer Complaint Coordinator to ensure complaints are progressed
- Continually improve processes and practices
Key Skills/ requirements
We are looking for professionals with these required skills to achieve our goals:
Ideally either a graduate with 6 to 18 months experience in Pharma Industry or a more experienced individual would also be suitable for this role.
- Experience of Batch Review in a pharmaceutical environment
- Good communication skills with the ability to build relationships and trust; and to be able to make decisions based on GMP principles
- Experience working in high pressure environments where there are likely to be conflicting priorities
- Recent experience of review of GMP Manufacturing and/or Packaging Documentation of a range of pharmaceutical dosage forms including sterile products within a Quality Assurance role would be an advantage e.g.
- Proven experience of knowledge of GMP principles and being a decision maker using this knowledge
- Strong attention to detail, problem solving skills and ability to learn new skills and apply them.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!