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QA Manager
2 weeks ago
Education : EQUIVALENTEXPERIENCE
**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**
The purpose of the QA Manager is to provide independent oversight of deviation and laboratory investigation matters, ensure that the local Quality System is maintained in compliance with cGMP through the self-inspection program and review and approve the Qualification documents to enable the supply of quality products and ensure adherence to ACVM GMP standards, Elanco New Zealand Standard Operating Procedures and Elanco Global Quality Standards.
**Responsibilities**:
- Review Deviations and Laboratory Investigations and ensure they are approved within due dates to enable the supply of quality products.
- Work cross functionally with Elanco business and quality to investigate the root cause of deviations and ensure appropriate Corrective and Preventative Actions (CAPA) are taken to prevent further deviations.
- Report on the Quality Metrics for deviation management each month to provide management and staff the increased visibility on the number of deviations being initiated, approved and back log. Utilise reporting to follow up and influence the timely investigation of deviation and closure of CAPAs.
- Provide training for Manufacturing and Quality staff on quality tools, as necessary.
- Review and approve high quality qualification documents associated with the manufacture and testing of Veterinary medicines in a timely manner ensuring cGMP compliance.
- Coordinate the self inspection program, audit internal departments and ensure compliance to local and global standards and ACVM GMP requirements.
- Manage external inspections according to global and local quality procedures and ensure completion of observations.
**Requirements**:
- Bachelor’s degree (preferably Masters) in Science (e.g. pharmacist, chemist, physician, biologist) or comparable qualification
- Minimum 3 years’ experience in an established QA function
- Detailed knowledge of GMP/GDP, QA/QC and/or ISO standards
- Additional skills, e.g. Change management, regulatory (Animal Health NZ), auditing experience, experience with contact with authorities and knowledge of the products
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
