Manager of Validation Processes

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Mundipharma Full time
Job Title: Validation Manager

Job Type: Permanent

Location: Cambridge/ Hybrid

Mundipharma is a worldwide healthcare organization with a footprint across multiple regions including Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Our commitment lies in delivering innovative solutions to patients in the domains of Pain Management, Infectious Disease, Consumer Healthcare, and other critical health challenges. Our core values, which emphasize Integrity and Patient-Centricity, guide our every action.

Job Purpose

The Validation Manager is tasked with leading the Validation department, ensuring the effective execution of validation initiatives. This role involves providing support and direction to the team to facilitate the successful completion of validation projects. The manager will oversee the timely implementation of essential maintenance programs, including cleaning validation, equipment requalification, hold-times for intermediates, and process validation, while ensuring adherence to GMP standards, industry best practices, and regulatory requirements.

Key Responsibilities
  • Oversee the recruitment, training, and development of team members, ensuring the availability of adequate resources.
  • Manage direct reports effectively by assigning tasks, establishing schedules, and addressing any issues that arise.
  • Set appropriate goals and objectives for staff members.
  • Ensure compliance in all validation activities, contributing to the organization’s readiness and compliance initiatives.
  • Develop a risk-based validation strategy, maintaining validation policies, procedures, and templates in accordance with GMP standards.
  • Support both internal and external audits, ensuring that documentation is prepared for inspection.
  • Assist the business in managing quality risks.
  • Support change control processes and conduct risk assessments (e.g., FMEA).
  • Facilitate continuous professional development for both personal and team growth to stay abreast of current technologies.
Essential Skills and Experience
  • A scientific degree in Pharmacy, Chemistry, Biology, Engineering, or a related field, or equivalent professional experience.
  • A minimum of 8 years of practical experience in QA and/or Validation roles within the Pharmaceutical or Medical Devices sectors.
  • Experience in a managerial or supervisory capacity.
  • Thorough understanding and application of GMP and Pharmaceutical regulatory standards.
  • Expertise in pharmaceutical validation requirements, including Eudralex Vol. 4 Annex 5, Annex 11, Annex 15, and GAMP5.
  • In-depth knowledge of various manufacturing processes and equipment for different dosage forms.
  • Extensive experience in supporting external audits as a subject matter expert.
We appreciate your interest in our organization. If this opportunity does not align with your career goals, we invite you to join our talent pools. This will allow our recruiters to connect with you when a suitable position becomes available based on your qualifications. We value your skills and expertise and look forward to the possibility of collaborating in the future.

Additional Job Description:

Primary Location:
GB Cambridge
Job Posting Date:

Job Type:
Permanent

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