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 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
We need : English (Good)
Type: Permanent
Payment:
Category: Others
