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POSITION SUMMARY
The Quality Operations and Product Disposition Senior Specialist will have an active role in batch review and certification for batches manufactured on site as well as partaking in batch review and certification of outsourced manufacturing & testing activities. Participate in the establishment, continuous improvement and maintenance of the quality management system.
In addition, assume an active role in internal and external audits, outsourced activities, equipment qualification reviews, analytical data review and interface with cross functional departments on quality matters.
The role will also ensure that all Manufacturing and Product release activities are in alignment with Zoetis Registrations and Regulatory Compliance.
POSITION RESPONSIBILITIES
Review & approval of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of current Good Manufacturing Practices (cGMP) and batch review and batch disposition process.
Partake in QA documentation management, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.
Support change management, deviations and corrective and preventative action (CAPA) systems as required.
Support ongoing review of events, deviations and non-conformances associated with batch release activities.
Support site risk management procedures.
Support ongoing running and maintenance of Electronic Quality Management System.
Support the implementation and continuous improvement of an effective quality management system including quality oversight across the site.
Write or assist in writing, reviewing and approval of SOPs and other GMP documents.
Provide QA support to Quality Control including review of Quality Control (QC) raw data.
Review and approval of non-conformance reports including deviations, laboratory investigations & environmental excursions.
Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved.
Support the ongoing site training system and deliver training modules where required
Participate in or lead internal and external audit including 3rd party audits and supplier reviews.
Participate in ongoing site data integrity projects.
Manage specific projects that may arise, in a timely and efficient manner.
Assist in supporting the qualification and periodic review of equipment.
Participate in set up of new electronic systems where required.
Overview product and cell bank stability programmes, submission of samples, filing of results and providing updates.
ORGANIZATIONAL RELATIONSHIPS
Working closely with multiple groups for fast-moving projects to ensure proper and timely communication
The role will involve interaction with internal departments QC, Production and Engineering primarily.
EDUCATION AND EXPERIENCE
Third level Degree in a life science discipline.
At least 5 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.
Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including Quality by Design (QbD) and Risk Management.
TECHNICAL SKILLS REQUIREMENTS
Experience of interaction with cross-departmental teams.
Excellent interpersonal and communication skills, meticulous eye for detail.
Self-motivation.
Computer literate.
Strong time management awareness and the ability to drive projects forward.
PHYSICAL POSITION REQUIREMENTS
Role will be based on site at Zoetis Tullamore site.
Physical conditions: lifting light weights (e.g. batch paperwork folders), sitting, standing, walking.
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.
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