Purpose of Role
The Validation Manager leads the site’s validation effort and compliance of equipment, systems and processes at Sanofi Ireland across both solid dosage forms and sterile products manufacturing.
- Development and Maintenance of risk based validation plans and strategies for the Sanofi Ireland’s manufacturing site. Maintain the site Validation Master Plan;
- Manage the process validation documentation process, through protocol generation, execution, and final approval. Ensure that all validation procedures are in alignment with current regulatory requirements;
- Recruit and train validation team. Provide leadership and development;
- Plan internal and external validation resources to ensure projects are completed in a timely manner, on budget and department goals are achieved;
- Author and/or review regulatory documentation related to validation activities (facilities, equipment and processes);
- Develop and own Validation department budget;
- Measure the Validation team’s performance against Key Performance Indicators; creates plans to improve the quality and efficiency through continuous improvement;
- Lead site preparation for regulatory audits with HPRA and FDA (and other) from a Validation perspective;
- Ensures Validation activity are managed in compliance with all required Sanofi and legal requirements (Health & Safety, cGMP, construction, environmental etc);
- Leads site effort in adhering to the requirements of computerised systems validation for new and legacy computerised systems;
- Monitors regulatory intelligence in validation expectations to ensure the site is always meeting the latest in regulatory expectations;
- Lead the site’s PCS management process to ensure current process control documentation is maintained current for all products manufactured on site.
Compliance Related Tasks
- Ensure that the validation status of equipment and systems are in compliance with cGMP at all times across both solid dosage forms and sterile products manufacturing;
- Ensure compliance to cGMP at all times.
- Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec);
- Post-graduate studies as appropriate to augment primary degree.
- 10 years’ experience working in a Healthcare-manufacturing environment – ideally part of which would be in the pharmaceutical sector;
- 5 years’ experience in validation environment in a leadership role;
- Project management experience.