Quality Assurance Lead

6 days ago


Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
Job Summary

Mundipharma is a global healthcare company seeking a highly skilled Quality Assurance Lead to manage the Validation department and oversee all activities related to validation projects. The successful candidate will be responsible for ensuring timely execution of maintenance programs, maintaining compliance with GMP, industry best practices, and regulatory expectations.

Key Responsibilities
  1. Recruit, train, and develop talent to ensure appropriate resources are in place.
  2. Effectively manage direct reports by assigning work, setting schedules, and resolving problems as needed.
  3. Identify goals and set objectives for staff to ensure alignment with company expectations.
  4. Maintain compliance in all aspects of validation, contributing to company readiness and compliance programs.
  5. Develop a risk-based validation strategy, maintaining validation policies, procedures, and templates in line with GMP requirements.
  6. Support internal and external audits, ensuring documentation is 'inspection ready.'
  7. Support the business in managing risk to quality.
  8. Effectively support change control activities and perform risk assessments (e.g., FMEA).
  9. Ensure personal and team continuous professional development plans are in place to stay up to date with current technology.
Requirements
  1. Scientific degree in Pharmacy, Chemistry, Biology, Engineering, or similar field.
  2. Practical experience (8+ years) in QA and/or Validation roles within the Pharmaceutical and/or Medical Devices industry.
  3. Managerial experience or supervisory responsibilities.
  4. Excellent knowledge and application of GMP and Pharmaceutical regulatory requirements.
  5. Expert knowledge and application of pharmaceutical validation requirements, including Eudralex Vol. 4 Annex 5, Annex 11, and Annex 15, GAMP5.
  6. Extensive knowledge and experience of various manufacturing processes and equipment for various dosage forms.
  7. Extensive experience in supporting external audits by customers and competent authorities as subject matter expert.


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