Product Quality Assurance Manager

4 days ago


Dundee, Dundee City, United Kingdom Randstad Delivery (GBS) Full time
Job Summary

We are seeking an experienced and highly motivated Product Quality Assurance Manager to lead our Quality Assurance team at Randstad Delivery (GBS). This leadership role is crucial in ensuring the independent approval of raw materials, process intermediates, and finished products in line with cGMP standards.

Key Responsibilities
  • Leadership & Team Development: Recruit, develop, and manage a team of Product Quality Assurance professionals. Foster a culture of accountability, responsibility, and high performance through regular performance reviews and clear expectation setting.
  • Compliance Oversight: Ensure thorough compliance audits of manufacturing records, including those related to rare reagents, buffers, bulk formulations, dispensing, kit packaging, and QC test records.
  • Material Control & Approval: Oversee material inspection and control within the ERP system, ensuring that sub-assemblies, intermediates, and finished kits meet specifications before approval or release.
  • Product Release Management: Collaborate with operations and quality teams to plan and manage product release schedules. Ensure final approval and release of finished products are in compliance with all relevant standards and regulations.
  • Cross-Functional Collaboration: Work as part of a cross-functional team to perform document and change control reviews, CAPA coordination, and ensure timely resolution of quality incidents and deviations.
  • Continuous Improvement: Utilize Key Performance Indicators (KPIs) and Root Cause Analysis tools to drive continuous improvement efforts in cost, quality, and delivery performance.
  • Compliance with Policies: Ensure adherence to all relevant policies and procedures, as outlined in the company handbook, and act as a deputy for the Site Quality Head when required.
Qualifications
  • Education: Degree level or equivalent, preferably in a life science discipline.
  • Experience: Proven leadership and management experience within a regulated industry, with a practical understanding of ISO 13485:2016 standards for in-vitro diagnostics.
  • Technical Skills: Strong knowledge of record audit, material approval processes, and risk management tools such as RCA, FMEA. Familiarity with ERP and EDMS systems, CAPA systems (Agile preferred), and proficiency in MS Word, Excel, and PowerPoint.


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