Job Description:
This position will report directly to the Rathdrum Site Quality Systems and Standards (QSS) Lead, serving as a partner alongside other stakeholders to enable site inspection readiness through the development and implementation of a robust Quality Management System.
Key Responsibilities:
* Working in Partnership with System and Sub System Owners to Design, deploy and maintain compliant, robust, aligned, lean and efficient quality systems and tools at the site to support GMS and commercial strategy, and to support the product lifecycle.
* Oversight of the site data integrity program and act as system administrator for key Quality Systems such as Trackwise (ETS), Document Management System (Veeva Vault), Learning Management System (LMS), Quality Master Data in SAP & ZLIMS, and systems where the system administrator is required to be independent from the user function Empower 3, other Lab and Operational computerized systems.
* Responsible for site Quality System Governance and Metrics and Leading Management Reviews to ensure QSS consistently remain in place, in use and in control, comply with Zoetis Global Quality Policies and Standards and meet the most current regulatory requirements and best industry practices.
* Evaluation, Approval & Monitoring of suppliers including Quality Agreements (End to End Supplier Approval and Management).
* Stewardship of the Change Control System with specific responsibility for Management of Regulatory Changes and Regulatory Submissions.
* Support the QSS Lead with the site Inspection Readiness programme including internal, regulatory and supplier inspection including management of Supplier audits from planning to close out.
* QA Review and approval of Analytical method transfer documentation; protocols, reports and support any associated investigations.
* Initiate and coordinate activities relating to Regulatory submissions.
* Support the preparation and development and ultimately approval of the Site Validation Master Plans in key areas, ensuring compliance with cGMP.
Requirements:
* Undergraduate degree in pharmaceutical, biological or chemical sciences.
* Relevant advanced degree preferred.
* 5+ years relevant experience in Pharmaceutical and/or Animal Health industry with experience in Supplier management / Auditing, Validation or Regulatory Affairs essential.
* Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles.
* Demonstrated knowledge and success in working with cross functional teams.
* Ability to develop and adhere to self-directed standard work- organized and methodical with ability to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team.
* Strong written and oral communication skills and ability to collaborate effectively with others.
Physical Position Requirements:
* This is a Rathdrum, Ireland Site based position.
* Travel may be required as part of the role, approximately up to 10% of the time.