Validation Specialist Ireland
3 semanas atrás
Join PSC Biotech Corporation as a Validation Specialist in Ireland and be part of a dynamic team that drives excellence in engineering validation. As a key member of our team, you will play a crucial role in ensuring the quality and compliance of our products.
Job Summary:We are seeking a highly skilled and experienced Validation Specialist to join our team in Ireland. The successful candidate will be responsible for designing, authoring, reviewing, and executing qualification and validation documentation, as well as providing technical input into quality notifications and investigations.
Key Responsibilities:- Design and author qualification and validation documentation, including cycle development studies and change controls.
- Review and approve qualification and validation documentation, ensuring compliance with regulatory requirements and company standards.
- Execute qualification and validation activities, including equipment and process validation, and provide technical input into quality notifications and investigations.
- Collaborate with cross-functional teams to drive a safe and compliant culture in the site.
- Support regulatory audits and submissions as required.
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
- Proven track record in delivering excellence in a GMP manufacturing setting.
- Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills.
- Exception/Deviation Management and Change Control experience.
- Leadership experience in technical-related projects.
- Knowledge of process monitoring systems, automation systems, and operational intelligence & data systems within a GMP manufacturing environment.
- Excellent communication, presentation, and interpersonal skills.
PSC Biotech Corporation offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Validation Specialist looking for a new challenge, we encourage you to apply.
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