QC Microbiology Specialist
- Recruiter
- Confidential
- Location
- Dublin
- Salary
- Competitive
- Posted
- 02 Oct 2021
- Closes
- 30 Oct 2021
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Contract
- Hours
- Full Time
QC Microbiology Specialist - Team Horizon
We are seeking applications for a QC Microbiology Specialist, you will be responsible for technical and quality oversight for activities within the QC Microbiology department, provide technical support regarding method verification, Environmental Monitoring, Utilities, and all other lab-based activities.
You will oversee the operation of a QC testing group by means of a hands-on approach to laboratory operations.
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.
* Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
* Support validation/verification and qualification of test methods and processes.
* Troubleshoot laboratory methods and instrument issues as they arise.
* Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
* Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA, and other relevant departments and to implement effective corrective and preventative actions.
* Lead and participate in Quality Risk Assessments relating to QC.
* Technical report writing in support of routine testing and method verifications.
* Perform technical review of data generated in laboratory, validation protocols and reports.
* Represent the QC department in internal and external audits where appropriate.
What you need to apply:
* Minimum of 5 years of experience in cGMP Quality environment.
* Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
* Good knowledge of current regulatory requirements for QC / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
* Experience in Quality Risk Management.
* Excellent knowledge of LIMS.
* Degree in Science/ Microbiology or related science
We are seeking applications for a QC Microbiology Specialist, you will be responsible for technical and quality oversight for activities within the QC Microbiology department, provide technical support regarding method verification, Environmental Monitoring, Utilities, and all other lab-based activities.
You will oversee the operation of a QC testing group by means of a hands-on approach to laboratory operations.
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.
* Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
* Support validation/verification and qualification of test methods and processes.
* Troubleshoot laboratory methods and instrument issues as they arise.
* Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
* Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA, and other relevant departments and to implement effective corrective and preventative actions.
* Lead and participate in Quality Risk Assessments relating to QC.
* Technical report writing in support of routine testing and method verifications.
* Perform technical review of data generated in laboratory, validation protocols and reports.
* Represent the QC department in internal and external audits where appropriate.
What you need to apply:
* Minimum of 5 years of experience in cGMP Quality environment.
* Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
* Good knowledge of current regulatory requirements for QC / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
* Experience in Quality Risk Management.
* Excellent knowledge of LIMS.
* Degree in Science/ Microbiology or related science