Senior Quality Operations Lead

Description

Based in Wellington, New Zealand you will manage compliance, product release and minor regulatory activities on site.

Key responsibilities.

• Provide in plant/on floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations.
• Review and approve executed manufacturing and packaging batch records.
• Provide manufacturing and packaging operations Quality oversight.
• Review and approval of manufacturing and lab investigations and CAPAs.
• Responsible contact for site license registration process including transitional facility compliance and management of GMP certificates.
• Provide feedback to site and quality global compliance auditing function on states of site compliance, inspection readiness, and progress against previous audit findings.
• Consolidate site audit data for tracking/trending for compliance communications to GMS and global quality compliance & auditing function.
• Lead the QO internal or external regulatory audits and vendor audits.
• Provide technical expertise as requested and conduct business interactions in ways that reinforce and compliment Zoetis site quality assurance programs.
• Develop a process to track and trend internal audit and inspection data and the creation resultant action plans as necessary.
• Consolidate outcome of BOH inspections, GQCA audits, self-inspections, regulatory letters, manufacturing alerts and other relevant documents for the site, contractor or supplier to identify trend and ensure CAPA plan is implemented.
• Ensure regulatory compliance through change control management approvals.
• Ensure product release in compliance with registration file including raw material and printed material release.
• Coordination and oversight of the site environmental monitoring program.
• Management of the site documentation system.
• Complete assessments of customer complaints.

Education and experience

• Science Degree or equivalent qualification and experience in Quality Assurance and Quality Management Systems.
• Proven Organisation skills
• Presentation skills
• Ability to work with regulators effectively to achieve business outcomes
• Understanding of quality control testing
• A proven ability to analyse, assess and deliver results for a given issue
• A demonstrated ability to work effectively and credibly with all levels of the manufacturing organisation
• A sound understanding of GMP as well as corporate and regulatory quality standards
• An understanding of large scale manufacturing
• The successful applicant will need to be Covid 19 X 2 vaccinated and be prepared to have tetanus vaccination due to workplace conditions.
• This is an On-Site role – 5 days per week, due to operational nature of the work.
• Computer literacy in word processing, spreadsheet analysis, presentation software and database software
• Ability to navigate & operate virtual meetings in various platforms

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues’ careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.

Diversity, Equity & Inclusion

Connected to our purpose and Core Beliefs, at Zoetis, we lead with inclusion. Our Diversity, Equity & Inclusion (DE&I) focus helps create an environment where each colleague can thrive. Our commitment to DE&I begins with our leadership team of diverse backgrounds, experiences and ethnicities, and it is demonstrated in our support of our colleagues and the animal health industry. We have nine colleague resources groups whose members spread awareness, foster inclusivity and make a positive impact on our business and communities.

Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a 2024 Catalyst Award recipient and a Top 50 Company for Workplace Fairness by Fair360 (formerly DiversityInc). Zoetis has also been named a Best Place to Work for LGBTQ+ Equality, a Best Company for Working Parents, a Top Company for Executive Women, among many others. Learn more here.

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