Validation Specialist
We are seeking a skilled validation specialist to fill this key role in our team. This position is based in Waterford, working with a pharmaceutical client.
About the Role:
* Develop and execute process validation protocols for equipment, systems, and processes.
* Implement quality assurance strategies to ensure compliance with US FDA and EU regulations.
* Provide technical guidance on current regulations and industry best practices for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Maintain accurate documentation throughout the validation lifecycle.
* Participate in external audits and support Site Change Control process.
* Troubleshoot validation issues associated with projects and process development.
Requirements:
* Degree in Science or Engineering.
* Previous experience in validation/product development is highly advantageous.
* Familiarity with Process Validation regulations, industry practices, and guidelines.
* Knowledge of GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO guidelines.
* Understanding of quality and compliance regulations.
* Ability to manage projects effectively.
* Strong knowledge of quality management systems.
* Excellent communication skills.
Why Choose Us:
We offer a dynamic work environment, opportunities for growth and professional development, and a commitment to excellence in all aspects of our business.