Process Validation Manager

Job title : Validation Manager

Job Type: Permanent

Location : Cambridge/ Hybrid

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

• Responsible for recruiting, training and developing talent and ensuring appropriate resources are in place
• Effectively manage direct reports by assigning work, setting schedules and resolving any problems as and when required
• Identify appropriate goals handset objectives for staff
• Responsible for ensuring compliance is maintained in all aspects of validation, contributing to the 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'
• Responsible for supporting the business in managing the risk to quality
• Effectively supporting change control activities and performing risk assessments (e.g FMEA)
• Ensuring personal and team continuous professional development plans are in place in order to stay up to date with current technology and

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 process and equipment for various dosage forms
• Extensive experience in supporting external audits by customers and competent authorities as subject matter expert

We appreciate your interest in joining our organisation. If the current opportunity doesn't align with your career aspirations, we encourage you to join one of our talent pools. By doing so, our recruiters will have the opportunity to connect with you when a suitable role becomes available based on your CV. We value your skills and expertise, and we look forward to potentially collaborating with you in the future.

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Additional Job Description:

Primary Location:
GB Cambridge
Job Posting Date:
2024-08-09
Job Type:
Permanent