Job description Posted 25 April 2022

Quality Coordinator

Harlow

Contract until December 2022

Up to £22 per hour PAYE / £29 per hour via Umbrella


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.

It is a fantastic role that offers a wide range of development and progression opportunities depending on your passion.

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/GSK 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

Basic Qualifications

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.

• Strong attention to detail, problem solving skills and ability to learn new skills and apply them.

• 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

Preferred Qualifications

If you have the following experience, it would be a plus:

• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.

• Previous involvement in Quality Deviations/Customer Complaints/Vendor Complaints, Change Controls and inspections/audits

• Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D