CAI is seeking an experienced QA Specialist to support a leading biotechnology client in Dublin. This role will focus on providing Quality Assurance oversight for analytical method transfers method validation activities and analytical equipment qualification within a GMP-regulated environment.
This is an excellent opportunity for QA professionals who enjoy working closely with QC laboratories validation teams and technical stakeholders to ensure the successful implementation of new methods equipment and processes while maintaining compliance with regulatory expectations.
Key Responsibilities
Provide QA oversight for analytical method transfers and validation programs.
Review and approve qualification validation and lifecycle documentation for laboratory systems and analytical equipment.
Support implementation of new analytical technologies and laboratory improvements.
Partner with QC Validation Engineering and Technical Services teams to ensure GMP compliance.
Review and approve deviations CAPAs change controls and risk assessments.
Provide QA guidance on validation strategies and regulatory expectations.
Support audit readiness and regulatory inspections.
Requirements
Degree in Science Pharmacy Biotechnology or a related discipline.
5 years QA experience within the pharmaceutical or biotechnology industry.
Strong knowledge of GMP FDA EMA and HPRA requirements.
Experience supporting analytical method transfers and method validation activities.
Strong understanding of change control deviations investigations and CAPA processes.
Excellent technical writing and document review skills.
Ability to work effectively across multidisciplinary project teams.
Strong communication and stakeholder management skills.
Eligible to work in Ireland
Why Join CAI Join a growing team delivering high-profile QA and validation projects. Competitive rates flexible project opportunities and strong career development. Be part of Irelands thriving life sciences sector.
About CAI
CAI is a global leader in commissioning qualification validation and operational readiness services for the pharmaceutical biotechnology and life sciences industries. We partner with leading manufacturers to deliver compliant efficient and innovative solutions that ensure quality and regulatory excellence.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
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IC
CAI is seeking an experienced QA Specialist to support a leading biotechnology client in Dublin. This role will focus on providing Quality Assurance oversight for analytical method transfers method validation activities and analytical equipment qualification within a GMP-regulated environment.This i...
CAI is seeking an experienced QA Specialist to support a leading biotechnology client in Dublin. This role will focus on providing Quality Assurance oversight for analytical method transfers method validation activities and analytical equipment qualification within a GMP-regulated environment.
This is an excellent opportunity for QA professionals who enjoy working closely with QC laboratories validation teams and technical stakeholders to ensure the successful implementation of new methods equipment and processes while maintaining compliance with regulatory expectations.
Key Responsibilities
Provide QA oversight for analytical method transfers and validation programs.
Review and approve qualification validation and lifecycle documentation for laboratory systems and analytical equipment.
Support implementation of new analytical technologies and laboratory improvements.
Partner with QC Validation Engineering and Technical Services teams to ensure GMP compliance.
Review and approve deviations CAPAs change controls and risk assessments.
Provide QA guidance on validation strategies and regulatory expectations.
Support audit readiness and regulatory inspections.
Requirements
Degree in Science Pharmacy Biotechnology or a related discipline.
5 years QA experience within the pharmaceutical or biotechnology industry.
Strong knowledge of GMP FDA EMA and HPRA requirements.
Experience supporting analytical method transfers and method validation activities.
Strong understanding of change control deviations investigations and CAPA processes.
Excellent technical writing and document review skills.
Ability to work effectively across multidisciplinary project teams.
Strong communication and stakeholder management skills.
Eligible to work in Ireland
Why Join CAI Join a growing team delivering high-profile QA and validation projects. Competitive rates flexible project opportunities and strong career development. Be part of Irelands thriving life sciences sector.
About CAI
CAI is a global leader in commissioning qualification validation and operational readiness services for the pharmaceutical biotechnology and life sciences industries. We partner with leading manufacturers to deliver compliant efficient and innovative solutions that ensure quality and regulatory excellence.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
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