QA Officer

Location Salisbury
Discipline: Life Sciences
Job type: Permanent
Salary: £29K
Contact name: Carrie MacDonald

Contact email: carrie@requireconsultancy.com
Job ref: REF: 6815
Published: 4 months ago
Expiry date: 01 December 2021

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!