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Validation Manager
2 months ago
About the Role
The Validation Manager at DNA Life Sciences leads all validation activities, ensuring compliance with EU GMP guidelines and other relevant regulations. This role is responsible for developing and implementing the Site Validation Master Plan (SVMP) and validation policies.
Key Responsibilities
- Lead the validation team and track departmental KPIs to ensure the team has the capacity and capability to deliver the SVMP schedule.
- Support validation and qualification activities for new facilities and ongoing operations, ensuring all systems comply with regulations.
- Develop the team's skills to handle inspections confidently and drive continuous improvement and best practices within the function.
- Manage the Validation Master Plan to ensure all systems comply with regulations and implement validation standards and operating procedures.
- Provide technical expertise and framework for validation documentation, planning and executing ongoing process verification and equipment re-qualification.
- Manage change controls, non-conformances, CAPAs, and effectiveness checks, and represent the site during inspections and audits.
- Advise on regulatory queries and submissions, ensuring protocol deviations are addressed promptly and applying Good Manufacturing Practice principles and promoting company values.
Minimum Qualifications & Experience
- Degree in science or engineering.
- Experience in biotechnology/pharmaceutical industries, specifically in GMP validation.
- Experience in aseptic/sterile GMP manufacturing.
- Strong leadership, communication, problem-solving skills, and a proactive approach.
- Knowledge of relevant industry standards and best practices (Annex 11, Annex 15, GAMP 5, ICH Q8/9/10).
