ReQuire Consultancy are working with an established business based at Porton Down Science Park, who have a new QA Officer opportunity within their Quality Department.
Reporting to the Product Quality Manager and supporting the wider QA team with the management of the non-conformance and CAPA systems to support the manufacturing and testing of products.
Main responsibilities include:
Support the co-ordination and planning of the In Process Team workload, ensuring Quality matters are considered and acted upon in a compliant fashion.
Actively participate in Quality investigations, change controls and risk assessments.
Facilitate and lead structured investigations.
Perform the review and approval of a number of key documents associated to the In Process Team including but not limited to: validation, SOPs, change controls, investigations, risk assessments, pre manufacturing checks, facility release.
Perform review of batch manufacturing records and release relevant material for the next stage of manufacture.
Provide appropriate QA oversight of manufacturing and testing processes within the In Process Team to support the business.
Participate in the data gathering/review for the quarterly trending reports and annual PQR for the related stage of manufacture.
Promote and enforce data integrity compliance within the In Process Team and across the business.
Liaise with customers, consultants and contractors as required.
Escalate relevant issues to line management.
Provide KPI reports measuring the performance of the team.
Person Specification:
Experience in operating quality systems in a GMP environment.
Proven background of preparing and providing accurate documentation.
Solid understanding of GMP, GCP, GLP, GDP and ISO.
Able to prioritise multiple tasks and manage a heavy workload.
Strong communication skills with all levels .
Excellent technical writing.
For more information, please contact Carrie today or click apply!