Until end of July 2022
£22 per hour PAYE OR £29 per hour via umbrella
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)