Site Quality Assurance Specialist - QSS

This position will report directly to the Rathdrum Site Quality Systems and Standards (QSS) Lead, and together with the QSS Lead will serve as a partner alongside other stakeholders to enable site inspection readiness through the development and implementation of a robust Quality Management System. The Rathdrum Site QA Specialist - QSS role is involved in the following activities; QMS Oversight and Management, Supplier Qualification and Management, Site Auditing Programme, Regulatory submissions, Analytical method Transfer and Validation Approvals, site Data Integrity Oversight and will serve as administrator for site Quality Systems: Document Management, ETS, LMS and Quality Master Data Approver for SAP and ZLIMS and independent System Administrator for Laboratory and Operations IT Systems as required. The QA Specialist- QSS may be required to perform tasks required by QA Specialist - Operations or QA Specialist Batch Release on a case by case basis where needed, once trained to do so.

Key objectives of this position include:

1. 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.

2. Oversee the site data integrity program and act as system administrator for key Quality Systems e.g. 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.

3. 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, to assure a compliant robust Quality system which is inspection ready. Use quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle and in compliance with ICHQ7

4. Evaluation, Approval & Monitoring of suppliers including Quality Agreements (End to End Supplier Approval and Management)

5. Stewardship of the Change Control System with specific responsibility for Management of Regulatory Changes and Regulatory Submissions.

6. 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.

7. QA Review and approval of Analytical method transfer documentation; protocols, reports and support any associated investigations

8. Initiate and coordinate activities relating to Regulatory submissions

9. Support the preparation and development and ultimately approval of the Site Validation Master Plans in key areas, ensuring compliance with cGMP; Facilities, Equipment, Utilities, Laboratory Methods , Process, computerized Systems. Monitor their execution and work with System and Sub System owners to ensure compliance and continuously improve.

10. Responsible for the lifecycle of Quality System documentation for Rathdrum i.e. design, preparation, implementation, deployment, training, retention and ongoing review and maintenance

11. Ensure GMP documentation is properly prepared, managed and archived 12. Support Development and implementation of the site training system for all GMP activities

Common Responsibilities for all Quality Colleagues

* Active participation in site Tier meetings

* Perform/Lead Internal Audits/Quality Walkthroughs.

* Support Internal Inspection Readiness, Corporate and Regulatory Inspections. * Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, ensuring quality is built in and all corporate and regulatory requirements are met

* Serving as a quality culture role model and instill a strong quality and compliance culture across the site.

* Assure the use of operational excellences tools in quality procedures and processes,

* Support the development of quality goals and targets as part of the organization's strategic plan,

* Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology,

* Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work. All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.

* Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.

* Perform role to a high standard and deliver on all assigned objectives/duties

This position will need to achieve results through colleagues with indirect reporting relationship, as part of the site recommissioning core project team through to commercialisation. The successful candidate will need to interact regularly with leadership at the site (quality and site heads, site recommissioning project manager), GMT, regulatory affairs, to assure quality goals and objectives are met.

All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures.

All employees are expected to model inclusion behaviours. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions.

EDUCATION AND EXPERIENCE

• 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 * Experience of using Software Tools for Documentation Management and Learning Management desirable

* ICHQ7 Manufacturing Site experience preferred

* Recognised auditing qualifications and experience preferred

* Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

• Demonstrated knowledge and success in working with cross functional teams e.g. supplier management.
• 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
• Exercises Good Judgment and Drives Change for Competitive Advantage
• Strong written and oral communication skills and ability to collaborate effectively with others
• Strong interpersonal, leadership and influencing Skills, communication and motivation.
• Drives for Superior Results and Passion to Win with demonstrated record in getting things done
• Inspires Continuous Improvement and Breakthrough Thinking - flexible and adaptable to new and innovative ideas
• Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
• Proficient in English
• Demonstrated written communication skills, as well as experience with presenting to leadership teams.
• Assertive
• Business Awareness & Continuity

PHYSICAL POSITION REQUIREMENTS

This is Rathdrum, Ireland Site based position.

* Travel may be required as part of the role, as needed to support audits - approx. up to 10% of the time.

* This position will require fluent use of teleconferencing tools, as well as Sharepoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network.

Please note this is a 12 month fixed term contract

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.