This position is a key player within the site CSV/CQV project team, and will be responsible for a number of important tasks including but not limited to:
- Completing lab-validation activities including analytical systems qualification.
- Support the preparation of GxP Computerised System Lifecycle documents, including validation plans, requirement specifications, risk assessments, qualification protocols, requirements traceability matrices and validation reports.
- Design, generate and execute test plans and test protocols, managing and reporting findings and non-conformances raised during all types of testing.
- Perform business analysis activities.
- Ensure that computer systems and their associated documentation are fully compliant with site specific policies and regulations, good manufacturing practices and industry regulations.
- Draft test cases for QC laboratory computerized system.
- Be responsible for establishing and revising of VP for QC laboratory computerized system.
- Lead risk assessment before test execution, such risk assessment includes but not limited to ERES assessment, system functional risk assessment.
- Responsible for review of the vendor validation documents, such as validation protocols and validation summary reports.
- Participate in deviation investigation, analysis and change assessment.
- Educated to Degree level in Engineering, Computer Sciences or related discipline.
- At least 5 years' experience working in the Life Sciences industry.
- Experience of Chrome and AxiChrome skids extremely beneficial.
- Experience of PLC/Automation systems validation required.
- 3+ years' experience working on green or brown field projects within a highly regulated GMP manufacturing operation in Pharma or Bio.
- A strong portfolio of Lab Systemes and Equipment Validation work is required and proven skill in this area.
- Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.
Competitive hourly rate offered for an initial 12-month contract.
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 7521041 for a confidential discussion.