Job title: Validation Manager
Job Type: Permanent
Location: Cambridge/ Hybrid
Company Overview
Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is 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. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.
Job Purpose
Responsible for managing the Validation department, overseeing all activities and providing support and guidance to the team as required in order to support the business with validation projects. You will be required to ensure timely execution of all required maintenance programs, such as cleaning validation, equipment requalification, intermediates hold-times and process validation, and maintain compliance of all validation processes and procedures to GMP, industry best practices and regulatory expectations.
Responsibilities
1. Responsible for recruiting, training and developing talent and 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 appropriate goals and objectives for staff.
4. Responsible for ensuring compliance is maintained in all aspects of validation, contributing to the company 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. Responsible for supporting the business in managing the risk to quality.
8. Effectively supporting change control activities and performing risk assessments (e.g., FMEA).
9. Ensuring personal and team continuous professional development plans are in place in order to stay up to date with current technology.
Key skills and experience
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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