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Senior Quality Associate

PE Global
Job LocationSpeke
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time

Job Description

This is an initial 12 month contract with strong possibility of extension.The purpose of this role is To support third party quality operations at EEM EMEA and ensure that third party products are produced and released according to the clients requirements. To operate and maintain quality systems which monitor the compliance ofthird party manufacturers and productsRole:

  • To perform QA oversight on assigned external suppliers and third parties manufacturing product for Elanco and ensuring, that the delivered products comply with Elanco quality standards and legal requirements.
  • To act as Authorized Person for release of products for shipment including material status change in SAP.
  • To review and approve production deviation reports provided by third parties for correctness and completeness including the assessment of suggested CAPA.
  • To review and assess external customer complaints in the global Elanco complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods.
  • To maintain a batch record review qualification status of contract manufacturers.
  • To monitor and to drive EEM-EMEA CAPA system.
  • To utilize established QA systems for the QA oversight of external suppliers and contractors and ensure that relevant quality agreements are current and in place, supplier risk assessments are periodically performed and Product Quality Reviews (PQR) meetexpectations.
  • To monitor third party KPIs to proactively detect and notify to QA management any compliance issue on supplier level that would risk supply of products.
  • To review Third Party Product Quality Reviews (PQR) for quality trends on supplier level including the implementation of necessary corrective actions and provide the Third Party QA Manager with a conclusive summary as base for his final review.
  • To overview and request timely annual Pharmacovigilance statements for PQRs.
  • To support QA management in any quality related matter.
  • To support QA BU Switzerland with releases to the market.
  • To represent the quality function within Elanco Basel and to give QA support in assigned projects and expert teams as SME
Requirements:
  • Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
  • Experience in quality operations in the GMP environment;
  • Excellent command of English, other languages are an asset;
  • Knowledge and understanding of regulatory requirements;
  • Good knowledge in office tools (e.g. Word, Excel, SAP).
  • Experience in customer complaint handling (desirable)
  • Experience in the negotiation QA contracts (desirable)
  • Experience in QA systems that support Third Party management (desirable)
  • Working experience within a global organization (desirable)
Interested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up to date CV to***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, weare making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you justwant to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in thisadvert.

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