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Snr Associate QC

Reference:JSC00030770j
Location: Dublin
Qualification:Degree
Experience:See description
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: QC Analyst

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
• Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
• Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.
• Writing equipment validation protocols and associated summary reports.
• Maintaining a current working knowledge regarding regulatory requirements for equipment qualification and calibration.
• Generation and resolution of protocol discrepancies as required.
• Alerting Quality Control Management if equipment fails to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
• Participation in technical project teams in order to act as a subject matter expert on instrument validation regulations and procedures.
• Serving as the point of contact with laboratory equipment vendors and engineers.
• Coordination of equipment repairs and maintenance with vendors/contractors and also carrying out equipment maintenance as required.
• Scheduling of repairs and maintenance in order to minimize level of down-time for lab equipment, and disruption to laboratory activities.
• Writing/contributing to equipment operating procedures and manuals.
• Designing and conducting training for QC staff, and other department staff as applicable.
• Owns and project manages change controls and adhere to Change Control metrics.
• Preparing and presenting periodic management updates on activities to senior management.
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
• Reviewing & filing of QC calibration & maintenance documentation.
• Coordinating the audit of new vendors.
• Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.
• Recognised as System Owner & Business Administrator for QC Equipment.
• A key contributor to Data Integrity Assessments for Lab systems
• Capable of defending Lab systems validation and data integrity philosophy in an Audit situation
• Any other tasks/projects assigned as per manager’s request.

Education & Experience

• Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation.
• Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.
• Key Values: Teamwork, Be Science Based, Collaborate, Communicate, Be Accountable



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