Are you a QC with proven experience of troubleshooting issues identified during laboratory systems validation? If you have the relevant experience, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior QC - Lab Sytems - Amgen
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description:
Responsible for authoring Validation Life Cycle documents for computer related systems, also responsible for executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen Dun Laoghaire.
Key Responsibilities:
Authoring, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
Writing equipment validation protocols and associated summary reports.
Maintaining a current working knowledge with regards to regulatory requirements for equipment qualification and calibration.
Generation and resolution of protocol discrepancies as required.
Alerting Quality Control Management in the event that 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.
Writing/contributing to equipment operating procedures and manuals.
Adhere to Change Control metrics.
Conduct periodic reviews of instrument validation as part of validation life cycle.
Conducting review of calibration and maintenance documentation related to laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
Filing of QC qualification, calibration & maintenance documentation.
Any other tasks/projects assigned as per manager’s request.
Requirements
B.S. degree in Chemical/Biochemical Engineering, Life Sciences, or Pharmaceutical Sciences
Minimum of 3 years’ experience in a cGMP environment, experience of executing analytical instrument validation would be a distinct advantage.
Good understanding of Windows® Operating Systems and proven experience of troubleshooting issues identified during laboratory systems validation.
Experience of authoring cGMP Validation documents in a controlled document system.
Experience of executing cGMP Validation documents in a controlled document system.
Experience of resolving Protocol Deviations.
Awareness of Change Control philosophy in the cGMP environment.
Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record / electronic signature integrity assessments
Knowledge of the methodology and instrumentation used for biopharmaceutical testing.
Ability to work on own initiative within a cross functional team environment
Package:
Minimum 12 month contract
Rate: €25 - €30 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Dublin
Amgen Jobs
Q
Are you a QC with proven experience of troubleshooting issues identified during laboratory systems validation? If you have the relevant experience, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior QC - Lab Sytems - Amgen
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description:
Responsible for authoring Validation Life Cycle documents for computer related systems, also responsible for executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen Dun Laoghaire.
Key Responsibilities:
Authoring, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
Writing equipment validation protocols and associated summary reports.
Maintaining a current working knowledge with regards to regulatory requirements for equipment qualification and calibration.
Generation and resolution of protocol discrepancies as required.
Alerting Quality Control Management in the event that 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.
Writing/contributing to equipment operating procedures and manuals.
Adhere to Change Control metrics.
Conduct periodic reviews of instrument validation as part of validation life cycle.
Conducting review of calibration and maintenance documentation related to laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
Filing of QC qualification, calibration & maintenance documentation.
Any other tasks/projects assigned as per manager’s request.
Requirements
B.S. degree in Chemical/Biochemical Engineering, Life Sciences, or Pharmaceutical Sciences
Minimum of 3 years’ experience in a cGMP environment, experience of executing analytical instrument validation would be a distinct advantage.
Good understanding of Windows® Operating Systems and proven experience of troubleshooting issues identified during laboratory systems validation.
Experience of authoring cGMP Validation documents in a controlled document system.
Experience of executing cGMP Validation documents in a controlled document system.
Experience of resolving Protocol Deviations.
Awareness of Change Control philosophy in the cGMP environment.
Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record / electronic signature integrity assessments
Knowledge of the methodology and instrumentation used for biopharmaceutical testing.
Ability to work on own initiative within a cross functional team environment
Package:
Minimum 12 month contract
Rate: €25 - €30 per hour
Contact
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact her by e-mail karen@jobcontax.com or phone +353-1 7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Jobs in Dublin
Amgen Jobs
Q
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
