Job Title: Quality Assurance Specialist
This is a 12 month contract for our pharmaceutical client based in Waterford. We are seeking an experienced professional with strong technical knowledge of process validation, regulations and industry best practices.
About the Role:
* Design and execute process performance qualifications and equipment validations.
* Provide technical guidance on current US FDA and EU validation requirements.
* Maintain validation documentation throughout the validation lifecycle.
* Support site change control processes and participate in external regulatory inspections.
* Troubleshoot validation issues associated with projects and process development.
Requirements:
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering Chemical/Mech/Elec.
* Previous experience in validation/product development would be highly advantageous.
* Strong knowledge of Process Validation regulations and industry best practices.
* Familiarity with GAMP, ISPE Baseline guides and steam/dry heat validation publications.
* Full understanding of relevant quality and compliance regulations.
* Able to execute projects to plan and possess good communication skills.
* Knowledge of quality management systems and MS Project/SAP packages an advantage.
Benefits: This is a great opportunity to develop your skills and gain valuable experience in the pharmaceutical industry.
Contact Information: Please submit your application through our website.