Job description Posted 23 November 2021

Quality Coordinator

Barnard Castle

Until end of July 2022

£22 per hour PAYE OR £29 per hour via umbrella


Job Purpose:

To ensure that products released for sale have been manufactured and packaged in accordance with the licensing requirements, Good Manufacturing Practice and business requirements; and to promote quality/compliance within area of operation.

 

Responsibilities applicable to all roles at Barnard Castle PSC site:

 

·      To work as a flexible and motivated member of the team.

·      To follow all Standard Operating Procedures (SOPs) and/or Standards of Work (SW) applicable and in which the individual has been trained.

·      To act at all times in compliance with Good Manufacturing Practices (GMP) and to report any quality issues.

·      To act in a safe manner, always (in compliance with the Health & Safety at Work Act, and all other relevant legislation) and to use GSK safety reporting systems to highlight potential hazards.

·      To remain up to date with all training requirements (both ‘classroom’ courses and computer- based training through the ‘My Learning’ internal platform).

·      To take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes.

·      To take part in Root Cause Analysis (RCA) and Corrective and Preventative Action (CAPA) processes.

 

Job Specific Responsibilities:

 

·      Leads, prioritises and provides an effective Product Release Service which ensures that all products released for sale or further processing have a quality appropriate to their intended use i.e. comply with Company GMP standards and Product Quality Specifications.

·      Ensure that Periodic Product Reviews are performed for all products.

·      Directs investigative work into products failing to meet requisite standards and recommend rejection or rework as appropriate. Develop and agree corrective actions arising from such incidents.

·      Directs investigative work into regulatory issues.

·      Technically Approves QA Standard Operating Procedures

·      Authorises non-QA Standard Operating procedures on behalf of OQ.

·      Approves procedures, complex protocols method statements utilised within relevant area of business.

·      Ensure that the Quality Manager and relevant Production Stream Management (as applicable) are notified of any deviations from GMP, which may have significant effect on product quality.

·      Provide GMP advice on an on-going basis.

·      Participate (as applicable) in internal audits of relevant production and support areas and manages action follow-ups.

·      Leads improvement projects

·      Promote Quality Improvement activities.

·      Ensure that Technical Terms of Supply are in place for relevant products.

·      Ensure that OQ staff in the area are aware of relevant Safety, Health and Environmental regulations and initiatives, COSHH surveys and safe working practice.

·      Provision of specialist advice (as applicable) on services, e.g. Building Management.

·      Management of agreed Service Levels on document/batch reviews.

·      Provide OQ representation on Projects (as applicable).

·      Provide OQ input to various aspects of Engineering functions specific to the area, e.g. Critical Device Rationales.

·      Investigate and report customer complaints as applicable.

·      Prepare OQ training material, and provide training as required.

·      Review Engineering Change Controls

·      Audit fronter for activity role (wider than local area)