Quality Assurance Manager and Responsible Person (Devices)

DETAILS:

• Full-time permanent position
• Remote UK working with some office presence (Wiltshire)
• Competitive package

THE ROLE:

• Maintain and Implement a Quality Management System
• Manage Outsourced Activities including:
  • Oversee of outsourced activity from a quality perspective
  • Establishment of Quality Agreement
  • Leading Audits
• Act as RP, RPi
• Ensure any required relationship with MHRA and support the company in maintaining WDA License
• GMP/GDP Corporate Audits
• Support Corporate GMP/GDP Projects
• Support Corporate Head of Quality, as required
• Involvement in MHRA audits
• Oversee transportation of Corporate Products

Full job description available on application

THE CANDIDATE:

• Science degree and at least 5 years relevant experience within the pharmaceutical industry in a quality assurance role
• Qualifications and experience to be named Responsible Person and Responsible Person Importation
• Minimum 3 years experience on a WDA as an RP
• Experience in pharmaceutical production and distribution
• Experience in execution of qualification/validation activities
• Experience in GMP/GDP audits
• Demonstrable sound knowledge of UK, EU and US regulatory requirements and GMP/GDP guidelines (including risk management)
• Previous MHRA Inspection experience essential
• Devices experience highly advantageous

• Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.