Senior Qc Associate

AMC1234

Senior QC Associate

Contract – 12 months

Dublin

Senior QC Associate

Would you like to join a leading and biopharmaceutical company in Dublin, to further develop your career?

This is an excellent opportunity to work on leading technologies in the biotech industry.

As a

QC Senior Associate

, you willbe responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.

To be successful in this role you must have a minimum of 3 years laboratory experience in cGMP laboratory environment including exposure to analytical instrument validation experience.

Responsibilities

Managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS)

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.

Commissioning of new laboratory equipment and facilities including developing lab equipment specifications

Writing equipment validation protocols and associated summary reports.

Conduct periodic reviews of instrument validation as part of validation life cycle.

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.

Writing / contributing to equipment operating procedures and manuals.

Designing and conducting training for QC staff, and other department staff as applicable

Project manage Change controls and adhere to Change Control metrics.

Periodic management updates on activities to senior management.

Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to.

AMC1234

Senior QC Associate

Contract – 12 months

Dublin

Senior QC Associate

Would you like to join a leading and biopharmaceutical company in Dublin, to further develop your career?

This is an excellent opportunity to work on leading technologies in the biotech industry.

As a

QC Senior Associate

, you willbe responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.

To be successful in this role you must have a minimum of 3 years laboratory experience in cGMP laboratory environment including exposure to analytical instrument validation experience.

Responsibilities

Managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS)

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.

Commissioning of new laboratory equipment and facilities including developing lab equipment specifications

Writing equipment validation protocols and associated summary reports.

Conduct periodic reviews of instrument validation as part of validation life cycle.

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.

Writing / contributing to equipment operating procedures and manuals.

Designing and conducting training for QC staff, and other department staff as applicable

Project manage Change controls and adhere to Change Control metrics.

Periodic management updates on activities to senior management.

Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to.

What you need :

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.

If you meet the minimum requirements, and feel this is the right role for you, please apply today!

For further details please contact Angela McCauley on 00 353 (0)876930951 or send CV in confidence to

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