Quality Assurance Specialist

1 week ago

Dublin, Ireland eTeam Inc Full time

Overview The Quality team is seeking a Quality Assurance Specialist to join our Dundalk facility. This role will provide critical QA oversight of Commissioning, Qualification, and Validation (CQV) activities to support the facility start-up project and its transition into the sustaining phase.
The successful candidate will ensure validation activities across facilities, utilities, equipment, computerized systems, cleaning, processes, storage, controlled temperature units (CTUs), and shipping are performed in compliance with regulatory requirements, cGMP, and company SOPs.
Responsibilities Provide QA oversight of all qualification/validation activities for facilities, utilities, equipment, computerized systems, cleaning, manufacturing processes, storage areas, CTUs, and shipping.
Review and approve validation documentation, including URSs, risk assessments, protocols, plans, and reports, ensuring compliance with SOPs, specifications, and cGMP requirements.
Oversee investigations, deviations, and change controls during validation activities, ensuring appropriate QA involvement and adherence to standards.
Review and approve SOPs related to validation/qualification activities.
Support regulatory inspections and client audits. Maintain expertise in cGMP and industry standards (e.g., EU-GMP, FDA, GAMP, ISPE, ISO, ASME, BPE).
Ensure timely execution and delivery of validation deliverables in line with project schedules.
Provide technical leadership and mentoring to the QA Validations team, including training, recruitment, and performance management.
Carry out additional quality activities as required.
Qualifications & Experience B.Sc. or B.Eng. in a scientific or engineering discipline (e.g., biochemistry, chemistry, engineering).
Strong experience in Quality Engineering/Assurance/Validation within biologics, pharmaceuticals, or medical device manufacturing.
Previous experience working in FDA/EU regulated environments.
Deep understanding of validation requirements for cGMP manufacturing facilities.
Solid technical aptitude with strong troubleshooting and root cause analysis skills (Ishikawa, FMEA, etc.).
Skills & Attributes Independent, self-motivated, and able to thrive in a fast-paced environment.
Strong planning, organizational, and time management skills.
Critical thinker with excellent problem-solving skills.
Effective cross-functional collaborator, able to work with both internal and external stakeholders.
Strong written and verbal communication skills.

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