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QA Specialist (Elanco)

QA Specialist (Elanco)
Primary Function
Assist QA Manager to conduct QA oversight on GMP documentation management, supplier management, change control and QC lab audit trail within Wusi site.
Primary Accountabilities/Responsibilities
  1. Ensure site archive rooms are well maintained and managed.
  2. Ensure batch production record, specification, analytical method and instrument logbook distribution/return in a controlled, traceable manner. Create RN for quality team in Regulus.
  3. Lead External Suppliers Qualification process.
  4. Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers.
  5. Responsible for coordinating and ensuring that all change requests is carried out according to the Elanco Global Quality Standard and local SOP.
  6. Timely conduct QC audit trail review on behalf of QA.
  • Bachelor or higher in Chemistry, Microbiology or another related science
  • 5-7 years experience in the pharmaceutical industry, with direct experience with Pharmaceutical / API products
  • Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA