Quality Systems Process Lead

7 days left

Location
Cheltenham, Gloucestershire (GB)
Salary
Competitive Salary in line with skills and experience
Posted
25 Apr 2021
Closes
25 May 2021
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

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