Consultant - Quality
Elanco
Basel, BS, CH
vor 1 Tg.
source : equest

Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet?

Search our job listings below. To ensure that 3rd Party Manufacturers are effective and compliant with the relevant regulatory and Internal requirements, thereby ensuring that the medicinal and biocidal products released onto the market are fit for their intended purpose.

To drive and maintain improvements in the quality systems and processes, related to 3rd party manufactures and suppliers.

To provide advice on all quality and compliance matters to ensure retention of the Product Licenses. Main Responsibilities · Assure the robust selection and on-boarding of Third Party Suppliers in compliance with both the regulatory / GMP requirement, in alignment with Elanco Global Quality Standards and relevant procedures.

  • Drive the utilization of Risk Management principles for third party oversight. · Implement and maintain oversight of Quality Agreements with Third Party Suppliers in accordance with the relevant regulatory requirements, the Elanco Global Quality Standards and relevant procedures.
  • Monitor Supplier / Contract Manufacturer or third party KPI’s to proactively detect compliance issues on supplier level in order to resolve them before they become problematic from a GMP and regulatory compliance / supply perspective.
  • Assure investigations are performed at Third Parties to GMP standards, to determine the quality impact on products and assure appropriate corrective and preventative measures.
  • Perform audits of Third Parties and Suppliers and monitor the corresponding corrective actions, in line with the global auditing team requirements / timelines.
  • Evaluate supplier Product Quality Reviews / Annual Product Reviews to pro-actively analyze and monitor quality trends on supplier level including the implementation of necessary corrective actions.

  • Assure in association with other relevant personnel that Product Quality Reviews / Annual Product Reviews are completed according to the required timelines.
  • Implement continuous improvement initiatives associated with quality systems to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance.
  • Perform the duties of an Authorized Person for release of products for shipment. Key Performance Indicators · Number of Veterinary Products / Biocides released per year.
  • Number of Quality Agreements reviewed, and or completed according to an agreed schedule. · PQR completed and reviewed to a defined schedule throughout the year.
  • Delivery of Quality System Optimization Projects. · Complete KPI tracking of designated TP Suppliers. Required skills, experience and education Formal Education in Science (Diploma, Master or equivalent education).
  • Proven experience within Quality Assurance in a Life Science industry including leadership role(s) >
  • Working experience within a global organization.
  • Thorough knowledge and understanding of Regulatory requirements and GMP standards.
  • Experience in leading the delivery of quality improvement initiatives
  • Experience of working with diverse and cross-functional teams
  • Excellent command of English and German; other languages are assets. 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
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