Site Quality Assurance Specialist-qss

POSITION SUMMARY This position will report directly to the Rathdrum Site Quality Systems & Standards (QSS) Lead and will serve as a partner alongside other stakeholders to ensure compliance and execution of batch release activities and enable site inspection readiness through the development, implementation and maintenance of a robust Quality Management System.
The role requires a deep understanding of GMP, regulatory requirements, and industry best practices to ensure the site remains inspection-ready and compliant.
The QA Specialist-QSS & Batch Release will have responsibility for ensuring that the process for the preparation of product release packs for Active Pharmaceutical Ingredient (API) / Drug Product Intermediate (DPI) and release of batches is in compliance with c GMP and the associated regulatory and registration requirements.
The QA Specialist - QSS & Batch Release may be required to perform tasks required by QA Specialist - Operations on a case-by-case basis where needed, once trained to do so.
POSITION RESPONSIBILITIES Batch Release: Final Review of Batch Documentation prior to final release - including but not limited to: Compilation of batch genealogy.
Assurance of approval of all input materials.
Assurance of closure of all associated change controls.
Assurance of closure of all associated Deviations and Lab investigations.
Final review of Executed Batch Record.
Final review of Executed Analytical Record.
Release of Product.
Coordinate the Annual Product Review Programme & Review the Annual Product Review reports.
Support investigations as required.
Ensure adherence to Regulatory Dossier Requirements.
Liaise with Qualified Person(s) as required during release activities for DPI.
Quality Systems Design and Maintenance: Collaborate with system and sub-system owners to design, deploy, and maintain compliant, robust, aligned, lean, and efficient quality systems and tools.
Support GMS and commercial strategy, and the product lifecycle through effective quality systems.
Data Integrity and System Administration: Oversee the site data integrity program.
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.
Quality System Governance and Metrics: Manage site quality system governance and metrics, including Quality Council.
Lead management reviews to ensure quality systems consistently remain in place, in use, and in control.
Ensure compliance with Zoetis Global Quality Policies and Standards, and current regulatory requirements.
Quality Risk Management: Utilize quality risk management processes to monitor and control systems.
Identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle, in compliance with ICHQ7.
Supplier Management: Evaluate, approve, and monitor suppliers, including quality agreements.
Manage the end-to-end supplier approval and management process.
Change Control and Regulatory Submissions: Steward the change control system, with specific responsibility for managing regulatory changes and submissions.
Initiate and coordinate activities related to regulatory submissions.
Inspection Readiness: Support the Quality Systems Lead with the site inspection readiness program.
Support internal, regulatory, and supplier inspections, including planning and closing out supplier audits.
Quality Documentation Review: Review quality documentation such as SOPs, LWIs, EOPs, specifications, protocols, reports, CAPAs, etc.
Ensure documentation is accurate, compliant, and current.
Quality System Documentation Lifecycle Management: Manage the lifecycle of quality system documentation for Rathdrum, including design, preparation, implementation, deployment, training, retention, and ongoing review and maintenance.
Ensure GMP documentation is properly prepared, managed, and archived.
Training and Development: Support the development and implementation of the site training system for all GMP activities.
Deliver training as required to ensure staff are knowledgeable and compliant with quality standards.
Investigation System Oversight: Prepare periodic investigation trend reports.
Sub-System Backup: Perform sub-system backup roles upon request of the Site Quality Standards Systems (QSS) Lead.
Additional Responsibilities: Continuous Improvement Initiatives: Lead continuous improvement initiatives to enhance the efficiency and effectiveness of quality systems.
Implement new technologies and best practices to drive improvements in quality processes.
Cross-Functional Collaboration: Work closely with other departments, such as manufacturing, GMT, and supply chain, to ensure quality standards are integrated into all aspects of operations.
Facilitate cross-functional teams to address quality-related issues and drive improvements.
Audit Management: Plan, conduct, and manage internal audits to ensure compliance with quality standards.
Prepare for and manage external audits by regulatory authorities and customers.
Risk Management and Mitigation: Develop and implement risk management strategies to identify, assess, and mitigate potential quality risks.
Conduct regular risk assessments and update risk management plans as needed.
Performance Metrics and Reporting: Develop and track key performance metrics related to quality systems.
Prepare and present regular reports on quality system performance to senior management.
Common Responsibilities for All Quality Colleagues: Active Participation in Site Tier Meetings: Engage in regular site tier meetings to discuss and address quality-related issues and initiatives.
Global Forums Engagement: Participate in global forums to share knowledge and network within the platform, fostering a collaborative environment.
Internal Audits and Quality Walkthroughs: Conduct and lead internal audits and quality walkthroughs to ensure compliance and identify areas for improvement.
Inspection Readiness Support: Assist in preparing for internal, corporate, and regulatory inspections to ensure the site is always inspection ready.
Continuous Improvement Initiatives: Drive continuous improvement and 5 S initiatives to enhance cycle time, productivity, efficiency, and quality of work using Lean methodology, ensuring all corporate and regulatory requirements are met.
Quality Culture Role Model: Serve as a role model for quality culture, promoting and instilling a strong quality and compliance mindset across the site.
Operational Excellence Tools: Ensure the use of operational excellence tools in quality procedures and processes to maintain high standards.
Quality Goals and Targets: Support the development of quality goals and targets as part of the organization's strategic plan.
Safety Compliance: Adhere to relevant safety statutory provisions, taking reasonable care for personal safety and the safety of others.
Comply with site safety rules and instructions, and report any accidents, injuries, defects, or hazardous situations.
Safeguarding Company Assets: Protect company assets and ensure resources are used prudently and responsibly.
High-Standard Performance: Perform assigned duties to a high standard, delivering on all objectives and responsibilities effectively.
ORGANIZATIONAL RELATIONSHIPS Key Interactions: Internal Stakeholders: Regularly interact with site leadership, including quality and site leads, as well as colleagues within the Global Manufacturing and Supply (GMS) team and regulatory affairs.
Collaboration and Reporting: Direct and Indirect Reporting: Achieve results through collaboration with colleagues who have both direct and indirect reporting relationships within the site team.
Leadership Engagement: Maintain regular communication with site leadership to ensure alignment on quality goals and objectives.
Compliance and Inclusion: c GMP Adherence: Ensure all employees comply with current Good Manufacturing Practices (c GMP) requirements, including Quality Manuals, Policies, and Procedures.
Inclusive Behavior: Model inclusive behaviors and foster a culture of inclusion, encouraging team members to share their knowledge and influence their work teams positively through daily interactions.
EDUCATION AND EXPERIENCE Required: Undergraduate Degree: Bachelor's degree in pharmaceutical, biological, or chemical sciences.
Relevant Experience: Minimum of 5 years of relevant experience in the Pharmaceutical and/or Animal Health industry, with current knowledge of c GMPs and regulatory guidance.
Quality Management Systems & Batch Release: Proven experience in Batch Release and Quality Management Systems including Supplier Management.
Quality Systems Development: Demonstrated success in developing, implementing, and maintaining Quality Systems and Standards at the manufacturing site level in accordance with ICHQ10 key principles.
Preferred: Advanced Degree: Relevant advanced degree (e.g., : Bachelor, Master's, Ph D) in pharmaceutical, biological, or chemical sciences.
ICHQ7 Experience: Experience at an ICHQ7 manufacturing site.
Auditing Qualifications: Recognized auditing qualifications and experience.
Software Tools: Experience using software tools for Documentation Management and Learning Management.
Lean Six Sigma (LSS) Qualification: Recognized LSS qualification (Yellow Belt, Green Belt, Black Belt).
TECHNICAL SKILLS AND COMPETENCIES REQUIRED 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.
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 to support audits and other projects - approx.
up to 10% of the time.
This position will require fluent use of teleconferencing tools, as well as Share Point technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network.
Full time Legal statement as below This job advert indicates the general nature and level of work expected.
It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.
Incumbent may be asked to perform other duties as required.
Additional position specific requirements/responsibilities are contained in approved training curricula.
Visa status re must be eligible to work and live in Ireland as below Colleague must be legally eligible to live and work in Ireland.
Summary of our Benefits In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few.
Please note that the benefits outlined are subject to change based on organization decision.
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