Associate Specialist QA Operations

Vor 5 Tagen


ValdeTravers District, Schweiz WuXi AppTec Vollzeit

Job Summary

WuXi AppTec is seeking a highly skilled Associate Specialist QA Operations to join our team. As a key member of our Quality Assurance Operations team, you will be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities

  • Support the design of Master Batch Records for bulk or packaged commercial drug products.
  • Review and approve executed batch records and associated QA samples.
  • Ensure compilation and archiving of documentation for compliance to GMP.
  • Handle deviations, complaints, and CAPA related to Couvet site.
  • Support GMP activities in cooperation with partners.
  • Write, revise, and recommend SOPs and quality documents.
  • Handle qualification and validation documentation for QA review.
  • Support during Authorities inspections and internal audits.
  • Represent QA within department and cross-functional project teams.

Requirements

  • BS in science or relevant discipline.
  • At least 1-2 years Quality Control and/or Quality Assurance experience in a pharmaceutical company or other related industry.
  • Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
  • Excellent interpersonal, collaborative, and organizational skills.
  • Strong written and oral communication skills in both French and English.


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Associate Specialist QA OperationsWuXi AppTec is seeking a highly motivated and detail-oriented Associate Specialist QA Operations to join our team. As a key member of our Quality Assurance Operations team, you will be responsible for ensuring the quality and compliance of our products and processes.Responsibilities:Support the design of Master...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWuXi AppTec is seeking a highly skilled Associate Specialist QA Operations to join our team. In this role, you will be responsible for ensuring the quality of our products and processes, working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues.Key ResponsibilitiesSupport the design...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWuXi AppTec is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.Key ResponsibilitiesSupport the design of Master Batch Records for bulk or packaged commercial drug products.Review and approve executed batch...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required and maintaining working...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWe are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team at WuXi AppTec. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.Key ResponsibilitiesQuality Assurance and ControlSupport the design of Master Batch Records for bulk...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at WuXi AppTec. As a key member of our Quality Operations team, you will be responsible for ensuring the quality and compliance of our products and processes.Key ResponsibilitiesSupport the design of Master Batch Records for bulk or packaged commercial drug...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at WuXi AppTec. As a Quality Assurance Specialist, you will play a critical role in ensuring the compliance of our processes and products with cGMP regulations.Key ResponsibilitiesSupport the Design of Master Batch Records: Collaborate with cross-functional teams to...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis role is a leadership position responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this position will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are met.Key...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health &...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job Title: Associate Director New Product IntroductionJob Summary:We are seeking an experienced Associate Director to lead our New Product Introduction (NPI) efforts at our Couvet, Switzerland site. As a key member of our Manufacturing, Science and Technology (MS&T) team, you will be responsible for ensuring the successful transfer of late clinical stage and...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health &...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis position is a leadership role responsible for the direct management of individual contributors and/or supervisors and/or managers. As a key player in the product manufacturing process, this role will work closely with QA, QC, production, and logistics departments to ensure the highest standards of quality and health & safety are...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryAs a key player in the product manufacturing process, this position will work closely with QA, QC, production, and logistics departments to ensure that packaging goods are produced according to supply needs and as per the highest standards of quality and health & safety.ResponsibilitiesManage the daily operations of the Bulk team, including...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy Quality Assurance team in a key role that will drive the quality of our external drug product manufacturing...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    About the RoleWe are seeking a highly experienced and skilled Associate Director to join our Cell Therapy QA External Drug Product Quality team at Bristol Myers Squibb. As a key member of our organization, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for...


  • Val-de-Travers, Schweiz WuXi AppTec Vollzeit

    Overview This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. Job Summary: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at WuXi AppTec. As a Quality Assurance Specialist, you will play a critical role in ensuring the compliance of our processes and products with cGMP regulations.Key ResponsibilitiesSupport the design of Master Batch Records for bulk or packaged commercial drug products,...


  • Boudry District, Schweiz Bristol-Myers Squibb Vollzeit

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients overcome life-threatening diseases. We are seeking an experienced Associate Director, Operations Portfolio Lead to join our team.Job SummaryThe Associate Director,...


  • Val-de-Travers District, Schweiz WuXi AppTec Vollzeit

    Job SummaryThe Senior Compliance Specialist for Pharmaceutical Manufacturing will lead the development and maintenance of GMP documents related to Bulk and/or Packaging Operations. This individual will be responsible for initiating and owning deviations related to Bulk and/or Packaging Operations, as well as leading investigation tasks as required. The...


  • Boudry District, Schweiz Bristol Myers Squibb Vollzeit

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy QA External Drug Product Quality team.About the RoleThis is a unique opportunity to work in a cross-functional team,...