Performance Qualification Lead

  • Contract
  • Meath

Website Ref: TPM03955

Summary:
A new and exciting opportunity has arisen at our Client’s biologics drug substance manufacturing facility in Dunboyne. The contract position of a PQ (Performance Qualification) Lead will perform a key management role in the start-up and operation of this Clinical to Commercial manufacturing facility. Using their expertise, the team will play a vital role ensuring the Performance Qualification of Plant Equipment at the facility.

Responsibilities:

  • Manage, plan and execute adherence to the Site Performance qualification Master Plan which includes Plant Equipment performance qualification.
  • Responsible for leading the PQ Team. Authoring and performing Performance Qualifications in compliance with the regulatory necessities.
  • Oversight of the Performance Qualification team, ensuring all projects are on schedule and meet the set timelines, the scope of which will include, HVAC, CTU’s (controlled temperature units), Clean wet utilities, containment devices (downflow booths, BSCs, autoclaves ).
  • Management of members of the team to ensure appropriate levels of training, competency and capability.
  • Manage, coordinate and guide the execution of the PQ Plan.
  • Effectively monitor and communicate the performance qualification activities and execution plan to other teams, project managers and key stakeholders.
  • Lead performance qualification activities and complete all associated project documentation in line with Quality and Regulatory expectations.
  • Author, review and execute performance qualification protocols for plant equipment.
  • Contribute to the overall performance qualification strategy for the facility.
  • Maintain performance qualification documentation through the performance qualification lifecycle.
  • Manage performance qualification documentation, test scripts, qualification protocols, summary reports and risk assessments.
  • Participate in Quality Management Reviews as a representative of the Performance qualification team.
  • Ensure compliance with environment, health and safety standards.

Qualifications & Experience:

  • Level 8 qualification or equivalent (Science, Engineering, Technical).
  • Demonstrated leadership with at least 8 years’ experience in a people management role.
  • A record in delivering results in a cross functional environment.
  • Competent Performance qualification, CQV or Technical Leader with credentials in delivery excellence in pharmaceutical operations.
  • Knowledge of Environmental and Safety regulatory/code requirements to Irish, European and International Codes, Standards and Practices related to Equipment and Maintenance.

To apply for this job email your details to orla.daly@tandempm.ie.