Quality Assurance Manager

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
Job Title: Quality Validation Lead 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. As a Quality Validation Lead, you will play a critical role in ensuring the quality and compliance of our products. Job Purpose: As a Quality Validation Lead, you will be responsible for managing the Validation department, overseeing all activities, and providing support and guidance to the team as required. You will ensure timely execution of all required maintenance programs, such as cleaning validation, equipment requalification, intermediates hold-times, and process validation. You will also maintain compliance of all validation processes and procedures to GMP, industry best practices, and regulatory expectations. Responsibilities:
  • Recruit, train, and develop talent, ensuring appropriate resources are in place.
  • Effectively manage direct reports by assigning work, setting schedules, and resolving problems as needed.
  • Identify goals and objectives for staff.
  • Ensure compliance is maintained 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 (e.g., FMEA).
  • Ensure personal and team continuous professional development plans are in place to stay up to date with current technology.
Key Skills and Experience:
  • Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or similar, or aligned working experience.
  • 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, including Eudralex Vol. 4 Annex 5, Annex 11, and Annex 15, GAMP5.
  • Extensive knowledge and experience of various manufacturing processes and equipment for various dosage forms.
  • Extensive experience in supporting external audits by customers and competent authorities as subject matter expert.

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