POSITION SUMMARY

The Quality Assurance Officer, reporting to the Quality Assurance Team Leader, will join a vibrant and dynamic Quality Assurance team covering release activities relating to the development and manufacture of GMP, RMU and RUO products. The Quality Assurance Officer will help maintain the current Quality Systems to ISO 9001 and applicable GMP standards, as well as get involved in continual improvement of these systems.

ESSENTIAL QUALIFICATIONS

• BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• A high level of experience working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
• Experience in a cGMP environment
• Proficiency with EudraLex Vol. 4 Part II or 21 CFR Part 820
• Familiarity with ISO 9001 or ISO 13485 standards
• Experience in documentation management systems and change control processes from a Quality Assurance perspective.
• Demonstrates strong team-working skills, clear communication, and a positive, can-do attitude.
• Excels at prioritising tasks, manages time effectively, and maintains meticulous attention to detail.
• Flexible mindset with proven problem-solving ability and a willingness to tackle challenges head-on.

ESSENTIAL RESPONSIBILITIES

• Release Activities: Review, approval and release Batch Production Records related to GMP and RMU products. Review Quality Control testing data to disposition bulk product and retail lots for all product lines (RUO, RMU and GMP).
• Lead campaign reviews/product quality reviews for GMP manufacturing campaigns including minuting and follow-up activities.
• Supplier Quality: Complete QA approval of incoming raw materials used in GMP and RMU manufacturing.
• Cleanroom activities: Support manufacturing activities within ISO 7 and 8 cleanrooms, including conducting environmental monitoring of classified areas. Issue and review packaging and labelling documentation for lot creation.
• Inventory Management and Stock control: Involved in custody and storage of the GMP and RMU products (bulk product, retail lots and retained samples). Complete Shipping activities for GMP and RMU products.
• Equipment review: Review calibration, preventative maintenance reports for compliance with tolerances and internal procedures.
• Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
• CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
• Documentation Management: Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
• Change Control: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
• Training: Deliver in internal quality related training sessions.
• Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings, and tracking completion of corrective actions.
• Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
• Any other task as required by the business.