Quality Director, EMEA External Manufacturing Drug Product
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 lead all personnel of EEM-EMEA Quality including the internal groups of Affiliate Switzerland and Quality Systems.

  • To have the QA oversight on external suppliers and third parties manufacturing product for Elanco and ensuring, that the delivered products comply with valid quality standards and legal requirements.
  • To ensure that all required quality systems for the import, export and release of pharmaceutical products are in place (e.g.
  • change control, complaint handling, deviation and CAPA handling, release documentation review) and meet GMP requirements.

  • To ensure the evaluation and approval of new suppliers and contractors according to Elanco and legal requirements is performed.
  • Established suppliers and contractors to be monitored on Key Performance (KPI / QPI) and GMP auditing outcomes. To ensure that all necessary QA instruments for the sourcing of GMP products from suppliers and contractors (e.g.

    Quality Agreements, Supplier Risk Assessments, Product Quality Reviews) are in place. · To represent the commercial quality function within the Elanco Site Basel and give QA support in project and expert teams for all quality-related matters as product transfers to new suppliers and contractors.

  • To liaise with Health Authorities in all quality related matters as reportable product quality incidents or recalls. · Ensures that all personnel of Quality Unit Basel / EEM EMEA are trained and developed according to their optimal potential.
  • Ensures to follow constantly on all current guidelines on Good Manufacturing Practice. · All legal requirements, especially the Swissmedic license for the QA operations in scope of Elanco Tiergesundheit AG Switzerland must be current and maintained.
  • Maintain and oversee the Quality Indicators of Quality Unit Basel / EEM EMEA 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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