Description:
The Quality Specialist is responsible for developing, modifying, and maintaining quality standards and protocols to support the manufacturing of finished and semi-finished products. This role collaborates closely with Engineering and Manufacturing teams to ensure compliance with internal standards, regulatory requirements, and continuous improvement objectives. The ideal candidate will demonstrate strong analytical skills, attention to detail, and experience in quality assurance within a manufacturing environment.
Key Responsibilities:
- Provide day-to-day quality support for manufacturing operations.
- Develop and implement methods and procedures for inspecting, testing, and evaluating products and equipment.
- Collaborate with Engineering and Manufacturing teams to ensure robust quality systems and standards are in place.
- Design, author, review, approve, and execute qualification and validation documentation, including cycle development studies, in line with internal quality standards and approval processes.
- Conduct quality assurance testing and statistical analysis to evaluate process and product performance.
- Recommend and implement corrective actions to ensure compliance and reliability.
- Design or specify appropriate inspection and testing equipment and mechanisms.
- Support documentation practices to ensure full compliance with internal and regulatory requirements.
- Participate in or lead quality projects and initiatives across functions as required.
- Utilize MES (Manufacturing Execution System); MES experience is an advantage.
- May act as a mentor to junior colleagues or provide guidance to team members.
Qualifications & Experience:
- University degree (Level 8 NFQ or equivalent) in a relevant scientific, engineering, or technical discipline.
- Minimum 2 years of professional experience in a Quality, Validation, or Manufacturing environment.
- Practical knowledge of quality systems, process validation, inspection techniques, and documentation standards.
- Experience in qualification/validation activities and working in a GMP-compliant environment.
- Proficiency with statistical analysis tools and techniques.
- MES experience is advantageous.