POSITION SUMMARY

This position will report directly to the Rathdrum Site Quality QSS Lead and will serve as partners alongside other stakeholders to ensure compliance and execution of batch release activities.

The Rathdrum QA Specialist-Batch Release will have responsibility for ensuring that the process for the release of API Batches and release itself is in compliance with cGMP and the associated regulatory and registration requirements. This role is required to collaborate with all relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. This will include batch disposition, documentation management and approval, product record review, investigations, complaints, change controls, audits, stability, and regulatory support.

The QA Specialist- Batch Release may be required to perform tasks required by QA Specialist - QSS or QA Specialist - Operations on a case-by-case basis where needed, once trained to do so

POSITION RESPONSIBILITIES

Key objectives of this position include:

• 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 instil 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 organisation'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.
• Ensuring that they perform their role to a high standard and deliver on objectives/duties assigned to them.

ORGANIZATIONAL RELATIONSHIPS

This position will need to achieve results through colleagues with a direct reporting relationship as well as indirectly, as part of the site recommissioning core project team through to commercialisation.

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 a current knowledge of cGMP's and regulatory guidance required.
• QP Qualification - or desire to become QP Qualified preferred
• Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles
• ICHQ7 Manufacturing Site experience preferred
• Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable

TECHNICAL SKILLS AND COMPETENCIES REQUIRED

• An ability to work in a dynamic, fast-paced and goal driven environment.
• Meticulous in attention to professional standards
• 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 to support audits for 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.

About Zoetis

At Zoetis we are passionate about our customers and the animals in their care. We discover, develop and manufacture the world's most innovative and effective products for animal health-medicines, vaccines, diagnostics, genetic tests, biodevices-and we are creating the next generation of integrated solutions and services to support this evolving industry. We know our people drive our success. Our colleagues are proud of our company culture and the meaningful role we play in caring for animals. The Zoetis Core Beliefs define the commitments we make to our colleagues, customers and stakeholders every day. They have guided the creation of our award-winning workplace and our proud position as a leading partner of choice in animal health.

Diversity, Equity & Inclusion

Our Colleagues Make the Difference, and we know their differences make Zoetis stronger. We strive to create an environment where each colleague feels valued and cared for and where we can be our best every day. Our Diversity, Equity & Inclusion (DE&I) focus and commitment begins with our leadership team of diverse backgrounds, experiences and ethnicities (50% of our executive team members are women), and it is demonstrated in our support of our colleagues and industry. Our Diversity, Equity & Inclusion Council, representing colleagues across locations, functions and communities, serve as ambassadors and champions for DE&I initiatives. In addition to the Diversity, Equity & Inclusion Council, Zoetis has six colleague resource groups that bring together colleagues who share similar backgrounds, experiences, or interests and work together toward goals aligned with our strategic business priorities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a Best Place to Work for LGBTQ Equality , a 100 Best Company for Working Mothers , a Top Company for Executive Women , among many others .

For animals. For health. For you.