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QA and RA Change Manager

Cignpost Diagnostics Ltd
Job LocationFarnborough
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

QA and RA Change ManagerJob descriptionAs the COVID-19 pandemic continues to evolve, there has been a substantial increase in the number of organisations requesting our expertise. To meet rising volumes, we are seeking to recruit a QA and RA Change Manager to join our QA team.Role Responsibilities

  • Input into project plans to define success criteria and deliverables related to compliance with accreditation and applicable regulations
  • Support project manager with impact analysis and risk assessment related to new product/services
  • Monitor regulations, review and conduct impact assessment of changes in regulations, and lead change into QMS and business processes
  • Review regulatory/QA changes at close out stages to confirm completeness and effectiveness
  • Liaise with local RA on international projects to review impact assessment and develop appropriate plans to update business processes and/or QMS.
  • Train the organisation on regulatory requirements
Job requirements
  • Educated to degree level in a science related subject
  • Experience of working with GxP systems / Diagnostics / Forensics or Food Hygiene analysis
  • Experience in leading QA or regulatory changes into business processes
  • Adaptable, able to manage changes in priorities
  • Ability to prioritise and manage workload
  • Self-learner, proactive with regards to CPD
  • Discipline and rigor in planning and implementing activities
  • Experience in risk assessment
  • IT fluency essential (MS Office suite)
  • Experience with eQMS (e.g. Q-Pulse) beneficial
  • Ability to balance compliance needs and business progress with the demands of a rapidly moving company is essential
  • Excellent communication skills, (both written and verbal), excellent interpersonal skills, team focused.
  • Work with a sense of urgency and have the ability to be impartial and objective.
Benefits
  • 25 days holiday
  • BUPA medical Health Care
  • Simply Health Cash Plan
  • Perkbox
  • Company Pension
  • On site parking (dependant on site)
Cignpost Diagnostics is committed to offering opportunities to all persons based solely on competence and individual merit, and not on any irrelevant factor such as age, sex, sexual orientation, gender reassignment, marital or civil partnership status, race,creed, colour, nationality, disability, background or social status. All employees have a duty to promote and comply with the equal opportunities policy.

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