Validation Operations Manager

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 various regions including Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Our commitment lies in delivering innovative therapies to patients, particularly in Pain Management, Infectious Disease, Consumer Healthcare, and other critical health challenges. Our core values, which emphasize Integrity and Patient-Centricity, guide our operations.

Job Purpose

The Validation Manager is accountable for leading the Validation department, ensuring the effective execution of validation initiatives and providing necessary support and direction to the team. This role is crucial in guaranteeing the timely completion of essential maintenance programs, including cleaning validation, equipment requalification, hold-times for intermediates, and process validation. Additionally, it is vital to uphold compliance with all validation protocols and procedures in accordance with GMP standards, industry best practices, and regulatory requirements.

Key Responsibilities
  • Oversee the recruitment, training, and development of team members, ensuring that adequate resources are available.
  • Manage direct reports effectively by delegating tasks, establishing schedules, and addressing any issues as they arise.
  • Set appropriate goals and objectives for team members.
  • Ensure compliance in all validation aspects, contributing to the organization's readiness and adherence to compliance programs.
  • Develop a risk-based validation strategy, maintaining validation policies, procedures, and templates in alignment with GMP standards.
  • Support both internal and external audits, ensuring that documentation is prepared for inspection.
  • Assist the business in managing quality-related risks.
  • Support change control processes and conduct risk assessments (e.g., FMEA).
  • Ensure continuous professional development plans are in place for both personal and team growth to stay abreast of current technologies.
Key Skills and Experience
  • Degree in Pharmacy, Chemistry, Biology, Engineering, or a related field, or equivalent professional experience.
  • At least 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.
  • Extensive knowledge of various manufacturing processes and equipment for different dosage forms.
  • Significant experience in supporting external audits as a subject matter expert.
We appreciate your interest in exploring opportunities with our organization. If this position does not align with your career goals, we encourage you to join our talent pools. This will allow our recruiters to connect with you when a suitable role arises 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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