QC Senior Associate
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1003164 |
| Job Views | 592 |
- Description
- Team Horizon is seeking a QC Senior Associate for our client based in Dublin. As a QC Associate you will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.
You will also be responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.
Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
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 with Amgen Global.
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 Amgen’s Lab systems validation and data integrity philosophy in an Audit situation
• Any other tasks/projects assigned as per manager’s request.
What you need to apply:
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.
