Quality Assurance Manager and Responsible Person (Devices)

Location
Wiltshire
Salary
Competitive salary and benefits
Posted
11 Jan 2021
Closes
02 Feb 2021
Ref
1101QAMRPD
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

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.