Senior GMP Quality Assurance Manager (Remote - UK)

Location
United Kingdom (GB)
Salary
Highly Competitive
Posted
27 May 2021
Closes
26 Jun 2021
Discipline
Quality, Auditor, GMP
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

The successful candidate will have solid GMP auditing experience, plus an additional GxP (GMP & GCP or GMP & GLP).

The Senior Quality Assurance Manager will provide a variety of QA services to external clients and conduct contracted activities in accordance with contractual requirements, regulations, guidelines, and standard operating procedures (SOP's).

Client/project-related activities 

  • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
  • Conduct technical peer reviews and provide feedback on client deliverables 
  • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable 
  • Provide strategic advice to clients on Quality Management System development and change 
  • Provide a consultancy service for GMP and/or additional regulations 
  • Develop and deliver training programs and/or materials 
  • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities  
  • Keep Zigzag’s relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication 
  • Foster and maintain good, professional working relationships with clients and identify new business opportunities 
  • Assist with the preparation of proposals and presentations to prospective clients  

Skills Required 

  • Thorough knowledge of GMP and/or other applicable regulatory requirements 
  • Excellent attention to detail, organisation, and prioritisation skills 
  • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
  • Self-motivation and ability to function independently and within a team  
  • Ability to function calmly under pressure 
  • Practical and enquiring approach to problem-solving 
  • Dedication to quality and reliability in all aspects of work 
  • Responsiveness to customer needs and focus on customer satisfaction  

Education or Equivalent Experience  

  • Life science degree or equivalent qualification or experience preferred 
  • Extensive auditing experience in GMP, and an additional GxP area

This is a remote/home-based position with an expectation to travel to client sites (up to 50%). 

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