Cpl Life Sciences

Quality Assurance Manager

30 Apr 2021
30 May 2021
Ed Taylor
Quality, QA / QC
Full Time
Contract Type
Experience Level

Job Title: Quality Manager
Work Location: Solent House
Start Date: ASAP
Division/Department: R&D
Reports to: R&D Director

Duties and Responsibilities:
Contribute to the company Quality strategy assuring early consideration of regulatory requirements and the scalable growth of the organisation
Implement and manage Quality Assurance and Control procedures ensuring compliance with any regulatory requirement, including but not limited to ISO9001, GAMP5
Support the R&D team in the training and implementation of quality systems, including review of design and test documentation
Manage assessment and control of product changes
Prepare, coordinate, and file regulatory submission documents as appropriate
Review and approve marketing materials to ensure compliance
Manage and support internal and external audits
Line manage the Quality team

Key Skills
Batchelors degree or higher
Demonstrable experience in quality systems for Instrumentation design and manufacture
Demonstrable experience with ISO9001, GAMP5 and ideally CSV against 21CFR/11
Experience in regulatory submissions and technical documentation for hardware, software and services.
Strong organisational skills; the ability to remain organised and productive in fast-paced work environment with competing priorities
Work independently and efficiently on assigned tasks and projects
Excellent communication skills and the ability to explain complex matters to non-experts
Ability to review and provide critical feedback on design documentations
Strong technical presentation skills

If you are interested then please apply or email directly at ed.taylor@cpl.com

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