Quality Assurance Specialist
Collins McNicholas is a leading recruitment agency providing expert recruitment solutions to businesses across various industries.
We are seeking a skilled Quality Assurance Specialist to join our team in the West of Ireland.
The successful candidate will be responsible for ensuring engineering work complies with GMP and site quality standards, overseeing equipment qualification, utility validation, and change controls, supporting C&Q lifecycle by reviewing and approving protocols and risk documents, leading or assisting with investigations, CAPAs, and timely issue resolution, contributing to projects for new equipment, process improvements, and upgrades, representing Quality in engineering initiatives like reliability and energy upgrades, and helping prepare for audits and inspections related to GMP and engineering systems.
Job Description:
Our Quality Assurance Specialist will play a crucial role in ensuring the highest standards of quality in our engineering work. They will oversee the qualification and validation of equipment, manage change controls, and support the C&Q lifecycle through protocol and risk document review and approval. They will also lead or assist with investigations, CAPAs, and issue resolution activities, contribute to projects for equipment upgrades, process improvements, and reliability initiatives, and represent Quality in engineering initiatives.
Key Responsibilities:
* Ensure engineering work meets EU GMP standards and site quality requirements.
* Oversee equipment qualification and validation processes.
* Support C&Q lifecycle through protocol and risk document review and approval.
* Lead or assist with investigation, CAPA, and issue resolution activities.
* Contribute to projects for equipment upgrades, process improvements, and reliability initiatives.
* Represent Quality in engineering initiatives and help prepare for audits and inspections.
Requirements:
* Degree in Engineering, Life Sciences, or related field.
* 5+ years of experience in GMP pharma, biopharma, or medical device industry.
* Strong knowledge of validation, engineering, and GMP principles.
* Experience with C&Q documentation, risk-based validation, and changes.
* Bonus: Familiarity with CMMS, BMS, and automation systems.
Benefits:
This is an excellent opportunity for a Quality Assurance Specialist to join a leading recruitment agency and make a real impact on our engineering work. We offer a competitive salary, opportunities for career growth and development, and a collaborative and supportive work environment.
About Us:
At Collins McNicholas, we are committed to delivering exceptional service and results to our clients. We specialize in matching talented professionals with top companies and are dedicated to building long-term relationships with our clients and candidates.