POSITION SUMMARY
The Product Release & Compliance Quality Assurance (QA) Specialist will play an active role in support
of the general site quality system, with a main focus on batch review and product compliance.
The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA
process and Standard Operating Procedures (SOPs) across all disciplines.
Key oversight responsibilities include, but are not limited to:
* Review of manufacturing batch records
* On-floor oversight and observations of manufacturing activities
* Support in identifying and resolving manufacturing-related issues
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.
* Complete data review at source to ensure data integrity, accuracy, and compliance with regulatory standards
* Preparing batch related documentation for batch release.
* Partake in QA documentation management, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.
* Support change management and corrective/ preventative action (CAPA) systems as required.
* Support ongoing review of events such as: laboratory investigations & environmental excursions and deviations.
* Complete manufacturing observations to ensure that all manufacturing activities comply with Good Manufacturing Practices (GMP) and site procedures.
* Provide QA support to Quality Control including review of Quality Control (QC) raw data.
* Support documentation updates.
* Review of temperature monitoring data of drug substance shipment.
* Support issuance and archival of batch related documentation.
* Support the ongoing site training system and deliver training modules where required.
* Partake in the vendor management process to include vendor assessments, auditing and qualification and supplier change notification. Support site Material requirement specifications.
* Partake in Internal and External audit program.
* Participate in ongoing site 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, Warehouse, GMT, Production and Engineering primarily.
EDUCATION AND EXPERIENCE
Third level Degree in a life science discipline.
At least 2 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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