CSV Engineer
- Ireland, Cork
- Contract
- Compliance / Quality Assurance
Do you want to be involved with exciting pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Engineer.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Analytical and microbiological method validations or Computer system validations.
- Planning and Design Qualification (URS, FRS, FAT, SAT) and Commissioning
- Risk Assessments (e.g. FMEA)
- Installation-, Operational- and Performance Qualification
- Documents for regulatory purposes
- Support root cause analyses and troubleshooting activities in case of deviations from Qualife
- ication/Validation PerspectivLead and participate in Risk Analysis of equipment, systems and processes
- Planning and execution of Computerised Systems Validation (CSV) in cooperation with IT and Process Automation
- Prior experience with quality systems is an advantage.
- Kneat and EVAL software is highly advantageous.
- Extensive professional experience in pharmaceutical Industry.
- Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods.
- Knowledge in automation and computer system validation.
- Project management knowledge, leadership capabilities with respect to quality topics.
- Experience with implementation of new pharmaceutical buildings and new line preferred.
#LI-AE1
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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Alex
I manage this role.