About the Company
Our partner company is a leading life sciences organization based in Westmeath, recognized for developing and manufacturing biopolymers for medical devices and pharmaceuticals.
Key Responsibilities:
* Represent the company during audits and site visits.
* Ensure effective implementation and maintenance of the quality management system (QMS).
* Report on QMS performance and recommend improvements to top management.
* Drive regulatory and customer requirements awareness across the organization.
* Lead and supervise Quality Assurance Specialists and Quality Control Technicians.
* Oversee QMS compliance with standards like ISO 13485, ISO 9001, and EXCi PACT.
* Manage documentation, training, and compliance strategies.
Job Requirements:
* Bachelor's degree (Level 8 or higher) in science, technology, engineering, or manufacturing.
* 7+ years of experience in the pharmaceutical or similar industry, including leadership roles.
* Strong knowledge of pharmaceutical/chemical manufacturing, expertise in QMS management, and regulatory compliance.
* Hands-on experience with CAPAs, NCRs, change management, and customer complaints.
* Familiarity with medical device regulations, process validation, and equipment qualification.
* Proficiency in Six Sigma and Lean methodologies.