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Sanofi

Validation Manager

Sanofi

Waterford, Ireland 

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.

Job Requirements

  • 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.

Qualifications

  • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec);
  • Post-graduate studies as appropriate to augment primary degree.

Experience

  • 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. 

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