Quality Systems Process Lead

Title: Quality Systems Process Lead                 

Rate: Competitive

Location: Cheltenham

Type: Permanent

My client is a leading orthopedic medical device organisation have an urgent requirement for a talented Quality Systems Process Lead. In this role will be responsible for owning the compliant implementation and maintenance of GMP systems used within the organisation

Responsibilities:

• work closely with Quality Assurance, IT, and users to ensure these systems are developed, implemented, and/or maintained in compliance to GAMP 5, 21 CFR Part 11, and Annex 11
• Maintain procedures/ tools to ensure compliant approach to computer system validations (CSV), and implementation of new systems

• Participate in software project teams, defining validation requirements and provide compliance guidance for validation activities

Requirements:

• Experience in working with regulations as defined under 21 CFR 820, ISO 13485, 21 CFR 11, Annex 11, GAMP
• Proven experience in performing computer validations
• Extensive experience with working in Quality organization with a demonstrated in-depth knowledge of Quality Systems
• Experience in implementing e-Quality Systems and project management experience is ideal

To Apply

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)20 3928 6631 or email on mowusu-ansah@planet-pharma.co.uk 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Agency providing Global Staffing services.