QC Analyst - System Owner / Process Owner - Dun Laoghaire

Office/Project Location: Dun Laoghaire, Dublin

Employment Type: Minimum 12 month contract

Pay: Hourly Rate €45 - €54 per hour

Experience: 5+ years laboratory experience in a cGMP laboratory environment including exposure to analytical instrument 

Visa: EU passport or Stamp 4 visa required

Job Description

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience on Ireland's leading aseptic manufacturing plant.

The Technical Services Specialist acts as a System Owner / Process Owner for the Technical Services Team. 

The Specialist is responsible for owning and delivering key quality, qualification and validation lifecycle documentation. 

The Specialist will support the Team manager in resource planning and resource support.

Planning, executing and documenting all the lifecycle deliverables of laboratory equipment for cGMP Quality Control multi laboratory facilities at Dun Laoghaire. 

The role includes introduction of new lab equipment and changes to existing lab equipment.

The projects include new capabilities and expansion of existing laboratory capacity as part of overall site expansion. The system owner will support all stages of qualification for the associated equipment.

Operational responsibilities will include routine support on existing lab equipment to meet business needs, ensuring inspection readiness and oversight of all service activities carried out by Calibration Technicians. 

The systems are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.

Planning and supervising routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. 

Reviewing & filing of QC calibration & maintenance documentation.

Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.

Conduct periodic reviews and audit trail reviews of as part of validation life cycle of computerised lab equipment.

Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.

Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.

Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.

Where applicable, owns and project manages change controls and adherence to Change Control metrics

Supporting and managing the addition of project components to Maximo

Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems

Any other tasks/projects assigned as per manger’s request

Responsible for authoring/owning, approving, executing all phases of Validation Life Cycle documents for computer related lab systems.

Responsible for peer reviewing/approving colleague and cross functional teams Validation Life Cycle documents or associated auxiliary documentation relating to system guides or system configuration or vendor qualification/service documentation.

Responsible for ensuring that all service activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo

Support laboratory investigations, 5 why etc in event of equipment failure / performance issue during analytical analysis.

Requirements 

Bachelor’s degree in a Science related field is required.

Minimum of 5 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.

Detailed knowledge of pharmacopeia analytical methodology, instrumentation and analytical techniques used for biopharmaceutical testing.

Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity 21 CFR part 11.

Demonstrated success in managing an equipment qualification or maintenance program advantageous.

The successful candidates will be involved with routine activities and may be requested to support project work. 

For the most part project work consists of the introduction and qualification of analytical equipment for use in routine QC analysis and the candidate should have specific hands-on laboratory equipment lifecycle and validation

Experience across entire project lifecycle, planning phase, implementation phase and reporting phase.

Experience of lab computerised system software applications as an elevated user or as a support function to lab during validation activities is an advantage.

Experience of electronic validation application kneat or ALM is an advantage.

Experience of document management system Veeva is an advantage.

Package

Contract rate of €45 - €54 per hour

Minimum 12 month contract

Work Hours: 08:30 AM to 5:00 PM, Monday - Friday (some flexibility possible if team coverage is maintained

Onsite Requirements:

Minimum expectation: 3 days/week onsite, occasionally up to 5 days according to business needs

At least one team member is onsite daily

Contact

Karen McHugh is the consultant managing this position.

If you are QC Analyst interested in roles based in Dublin, you can contact Karen by e-mail at karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of QC Analysts in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.

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