I am working with my client on a very exciting CQV Lead role in a Biopharmaceutical company based near North-West Dublin.
The successful person will play a key management role in the start-up of this manufacturing site. You will be responsible for all CQV activities in adherence with the site validation master plans. This role is a permanent position and will predominantly be based on site.
Level 8 degree in Science, Engineering, or a technical discipline essential.
Minimum 8 years' experience in a lead/management role.
People management experience essential.
Proven CQV or Validation experience in the pharmaceutical industry.
Familiarity with regulatory requirements to EU and International standards in relation to equipment and maintenance.
Knowledge of a Maintenance management system desirable.
Oversee all Commissioning, Qualification and Validation activities on site to meet set timelines.
Mentor a team of engineers, specialists, and contractors on site.
Manage, plan, and execute plant and process equipment validation, requalification, and validation of utility systems according to the Validation master plan.
Authoring and performing IQs, PQs and OQs in line with regulations.
Participation in periodic reviews during product life cycle.
Lead validation projects and complete associated documentation.
Participate in Quality Management reviews
Ensure all compliance with environmental, health and safety.
Identify training needs and ensure training is provided to carry out duties effectively.
If this role is of interest to you, please click 'Apply Now' or for more information contact Aoife on email@example.com or 021 2300 200.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.