QC Instrument IQ/OQ Coordinator
Pfizer Pharmaceuticals - Little Islan, Cork
The QC Instrumentation and Qualification Coordinator will be responsible for the installation and qualification of new equipment as well as upgrading existing instruments to the required standard.
Scope of responsibilities:
• Source and procure suitable laboratory instruments.
• Partner with vendors regarding delivery, installation and qualification of laboratory instruments.
• Review and approve vendor supplied qualification documentation.
• Design, prepare, execute, review or approve site qualification documents as required in accordance with GMP regulations, applicable safety considerations, applicable site procedures and data management principles.
• Partner with other QC and site project teams to meet project milestones and deliverables.
• Reviews, revises and implements calibration, qualification and preventative maintenance program for equipment in accordance with GMP regulations, applicable safety considerations, corporate quality standards and best maintenance practices.
• Adequately train and ensure all users are assigned correct security profiles.
• Negotiate service contracts and call outs to reduce equipment costs.
• Provide technical support to QC and other colleagues as required.
Qualifications (Training, Education & Prior Experience):
• Diploma/Degree in IT based or other science/engineering related discipline.
• Qualification in Chemistry would be an advantage.
• Experience in pharmaceutical industry or other regulated industry.
• Analytical experience with knowledge of laboratory instrument calibration and qualification is preferred.
• Good problem solving skills and ability to troubleshoot instrumentation and methodology.
• Be a self-starter with the ability to work on their own initiative.
• Knowledge of laboratory software and hardware applications would be an advantage.
• Ability to work on own initiative and be responsive to changing and demanding needs.
• Proficient in computer operating systems and applications such as windows, MS word and Excel.