Role: Quality Assurance Manager
Location: Dundee
Pay Rate: £22-£27 per hour
Start Date: ASAP
Position Overview:
We are seeking an experienced and highly motivated Product Quality Assurance Manager to lead our Quality Assurance team. This leadership role is crucial in ensuring the independent approval of raw materials, process intermediates, and finished products in line with cGMP standards. The successful candidate will oversee the compliance audit of manufacturing and quality control records, manage material inspections, and take full accountability for the release of finished in-vitro diagnostic products.
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.
Why Join Us?
This is a key leadership role offering the opportunity to significantly impact the quality assurance processes within a dynamic and innovative environment. If you are a proactive leader with a passion for quality and a track record of success in a regulated industry, we encourage you to apply.
How to Apply:
Interested candidates are invited to submit their CV and cover letter to [email address] with the subject line "Product Quality Assurance Manager Application."
This advertisement highlights the essential details and responsibilities of the role, targeting qualified candidates with relevant experience and expertise. Adjust contact information and company-specific details as needed.
Randstad Business Support is acting as an Employment Business in relation to this vacancy.