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Quality Assurance Associate job in Liverpool at PE Global International

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Quality Assurance Associate at PE Global International

Quality Assurance Associate

PE Global International Liverpool, Merseyside Full Time
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To support third party quality operations in Basel and ensure that third party products are produced and released according to our requirements. To operate and maintain quality systems which monitor the compliance of third party manufacturers and products.
• To perform QA oversight on assigned external suppliers and third parties manufacturing our products, ensuring, that the delivered products comply with legal requirements and quality standards.
• Support and provide Quality input for qualification and validation activities at Third Parties and support product launches.
• Manage and support our change control activities and with Third Parties.
• Support Regulatory submissions.
• To act as Authorized Person for release of products for shipment including QA 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 complaint system including the evaluation of the complaint investigation for correctness and an assessment of proposed CAPA within the due time periods.
• 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) meets expectations.
• To monitor third party KQI’s to proactively detect and notify to QA management any compliance issue on supplier level that would risk supply of products.
• To represent the quality function and to give QA support in assigned projects and expert teams as SME.
• 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 support QA management in any quality related matter
• To represent the quality function and to give QA support in assigned projects and expert teams as SME.

Required
• Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering;
• Experience in quality operations in a GMP environment;
• Excellent command of English, other languages are an asset
• Knowledge and understanding of regulatory requirements;
• Very good knowledge in office tools and SAP (e.g. Word, Excel).

Preferred
• Good negotiation and influencing skills
• Result driven and customer focused
• Experience in customer complaint handling;
• Experience in the negotiation QA contracts;
• Experience in QA systems that support Third Party management;
• Working experience within a global organization.

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, we are 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 just want 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 this advert
 

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Job ID: 213569203

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