Batch Release & Quality Improvement Team Leader (214/06)

Our prestigious partner is an industry-leading global player, developing and manufacturing pioneering medical products under their own brand as well as providing custom device solutions for the world’s leading pharmaceutical and diagnostic companies.

Role Purpose

To effectively manage the Quality Batch Release Team to enable timely release of assembly and moulding batches. – Management of the Quality Analyst and provide quality oversight of the manufacturing areas. – To proactively drive and improve compliance adherence in respect to the company’s documented Quality System and the requirements of ISO 13485, CFR 820, CMD/CAS, Directive 43/92 EEC, Medical Device requirements and EU GMP

Duties include (but not limited to)

• To lead and manage the Quality Batch Release Team to ensure the duties are performed to the requisite standard
• Attend batch release update meetings to determine priorities of the batch release team
• Responsible for the timely approval and release of medicinal product.
• To lead and manage the Quality Analyst to ensure the duties are performed to the requisite standard.
• Produce appropriate KPIs and RFT figures for the Tier 2 and Tier 3 process.
• Maintain, update and improve the moulding and assembly batch file process.
• Standardise GMP within the batch release team.
• Improve batch release process times
• Perform General Area Line Assessments (GALA) at the Cotswold site in accordance with a designated program.
• Actively determine and lead agreed quality improvement projects.
• Support the development of a Continuous Improvement culture within the division.
• Work with other areas within Quality and across the business (e.g. Moulding, Assembly, Warehouse) to drive and support improvements.
• Establish and maintain documented quality systems within the division which meet the requirements of ISO 13485, 21 CFR part 820 and EU GMP, which are best practice and meet the needs of the business.
• Drive prompt investigation and resolution of quality issues.
• Facilitate timely implementation of appropriate exception documents.
• Support Regulatory and Customer audits.
• Assist in the preparation, responses and maintenance of external audits and audit folders.
• Perform internal audits in accordance with the company internal audit program.
• Coordinate and organise monthly / quarterly medicinal review meetings.
• Perform any other duties as required by the Group Product Quality Manager and Site Product Quality Manager

 You will be/have

• In possession of professional education / qualifications is a distinct advantage
• A good level of written English for report writing
• A qualified lead auditor (qualified auditor)
• Able to build excellent relationships at all levels.
• Highly motivated / self-starter / resilient
• An effective team worker
• Good time-management skills
• Strong communication skills
• Good presentation skills
• Hands-on style
• Curious and analytically minded.

What’s on offer?

• A competitive salary – please contact me for details
• A superb company benefits scheme

Interested?

If you have read this job description and would like to apply, please send an up to date CV to matt@maydayprofessionals.co.uk. For more information, please call 01295 266288 and speak to Matt. I look forward to hearing from you!