Quality Assurance Lead

6 days ago

Cambridge, Ontario, Canada Mundipharma International Full time
About the Role

Mundipharma International is a leading global healthcare company with a presence across various regions. We are dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease, and Consumer Healthcare, as well as other severe and debilitating disease areas.

Job Purpose

The Quality Assurance Lead will be responsible for managing the Validation department, overseeing all activities, and providing support and guidance to the team as required to support the business with validation projects. This includes ensuring timely execution of all required maintenance programs, such as cleaning validation, equipment requalification, intermediates hold-times, and process validation, and maintaining compliance of all validation processes and procedures to GMP, industry best practices, and regulatory expectations.

Key Responsibilities

  1. Recruit, train, and develop talent, ensuring appropriate resources are in place.
  2. Effectively manage direct reports by assigning work, setting schedules, and resolving any problems as and when required.
  3. Identify and set goals and objectives for staff.
  4. Ensure compliance is maintained in all aspects of validation, contributing to the company's expectation readiness and compliance programs.
  5. Define 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 the 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, or aligned working experience.
  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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