Quality Assurance Specialist Role Overview
This role entails overseeing validation activities to ensure compliance with regulatory requirements. The specialist will be responsible for validating facilities, utilities, equipment, computerized systems, cleaning processes, manufacturing processes, storage areas, controlled temperature units (CTUs), and shipping processes.
Key Responsibilities:
* Ensure quality oversight of qualification/validation activities.
* Review and approve validation documentation for conformance to SOPs, specifications, and other applicable acceptance criteria.
* Provide support in Regulatory inspections and Client audits.
* Maintain validation status of the facility by providing QA validations expertise.
Key qualifications include a B.Sc or B.Eng in a Scientific or Engineering related discipline, 3+ years of experience in Quality Engineering/Quality Assurance/Quality Validations roles, and strong technical aptitude.
Essential Skills and Qualifications:
* Bachelor's degree in a Scientific or Engineering related discipline.
* Minimum 3 years of experience in Quality Assurance/Quality Validations roles.
* Strong technical knowledge and analytical skills.
* Excellent communication and interpersonal skills.
Working Environment:
Join a leading multinational in Dundalk, working on validation activities ensuring compliance with regulatory requirements.