Quality Coordinator

GSK; Ware; On-site; GBP 30,000 - 60,000; Full time

Job description

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at the GSK Ware Manufacturing Site. This entails monitoring all quality related systems, improvement procedures and documentation (including analytical data and information), ensuring that products released have been manufactured and packaged according to all Regulatory and cGMP requirements (including appropriate certification for EU markets).

Job Purpose:

Reporting into a Quality Operations Managers, you will support the Operational Quality (OQ) group by performing documentation reviews (as part of the overall manufacturing process to release product to market) to help the function ensure that products released to market conform to registered standards and are manufactured to cGMP.

Key Responsibilities:

1. Support order fulfilment by effective liaison with Production.
2. Make informed decisions on the suitability of products to be released for sale under the general guidance and with responsibility to the QPs (Qualified Persons).
3. Check all Usage Decisions to ensure that products released from OQ conform to the required quality standards (by reviewing Production and Quality Assurance (QA) documentation ensuring that all information is completed correctly as required by local SOPs (Standard Operating Procedures).
4. Generate batch certificates and supply to the market or releasing site.
5. Work closely with Production to ensure the batch document review and usage decisions are carried out efficiently.
6. Maintain a system for documentation, tracking and recording the progress of batches through the release system, and bring to the attention of the Quality Managers (QMs) any deviations from GMP noted during documentation review, self-inspection or at any other time.

As part of the quality assurance team, you will promote team working and effective communication across the Ware site.

This role is currently aligned to support the Respiratory Supply Chain (RSC).

Operational Quality – Please note that this role requires the successful applicant to be based/work in the GMP area for the site. The role operates during the standard working week (Monday to Friday).

About You:

As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has strong experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve and drive performance. You will have a continuous improvement mindset and be able to work in a changing environment. Effective written and verbal communication and good interpersonal skills, as well as the ability to organise and prioritise workload, are considered important skills.

Basic Qualifications:

1. Relevant experience (eg; obtained from working in a highly-regulated manufacturing environment, like a Pharmaceutical Manufacturing Facility).
2. Knowledge/experience of QMS (Quality Management Systems).