Quality Assurance Manager

4 weeks ago


Wilmslow, Cheshire East, United Kingdom Mundipharma Full time
Job Title: Quality Validation Manager Job Type: Permanent Location: Cambridge/Hybrid At Mundipharma, we are dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease, and Consumer Healthcare. Job Purpose: As a Quality Validation Manager, you will be responsible for managing the Validation department, overseeing all activities, and providing support and guidance to the team. Your primary goal will be to ensure timely execution of all required maintenance programs, such as cleaning validation, equipment requalification, intermediates hold-times, and process validation. Key Responsibilities:
  • Recruit, train, and develop talent to ensure appropriate resources are in place.
  • Effectively manage direct reports by assigning work, setting schedules, and resolving problems as needed.
  • Identify goals and set objectives for staff.
  • Maintain compliance in all aspects of validation, contributing to company expectation readiness and compliance programs.
  • Define a risk-based validation strategy, maintaining validation policies, procedures, and templates in line with GMP requirements.
  • Support internal and external audits, ensuring documentation is 'inspection ready.'
  • Support the business in managing risk to quality.
  • Effectively support change control activities and perform risk assessments.
  • Ensure personal and team continuous professional development plans are in place.
Requirements:
  • Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or similar.
  • Practical experience (8+ years) in QA and/or Validation roles within the Pharmaceutical and/or Medical Devices industry.
  • Managerial experience or supervisory responsibilities.
  • Excellent knowledge and application of GMP and Pharmaceutical regulatory requirements.
  • Expert knowledge and application of pharmaceutical validation requirements.
  • Extensive knowledge and experience of various manufacturing processes and equipment.
  • Extensive experience in supporting external audits.


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