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The QA Manager (f/m/d) within QA Analytics ensures that all processes within the Quality Control (QC) functional areas comply with GxP, data integrity, regulatory requirements, and internal/external quality standards. As a Quality and Compliance representative for a particular functional area, you serve as a key member in cross-functional teams, acting as an interface between QC and QA Operations and interacting with senior stakeholders across the site.

Tasks

  • Represent QA Analytics in cross-functional teams and meetings.
  • Represent QA concerns to Quality Control (QC) and ensure GxP requirements are met and global/local procedures (SOP) are followed.
  • Review and approve QC/Analytical Development (AD) related documents (e.g. method transfer documents, method validation documents, SOPs).
  • Review and approve TW records related to QC processes.
  • Ensure QC deviations/investigations are appropriately investigated and documented following regulatory requirements.
  • Act as decision-maker during QC deviations/investigation process.
  • Drive QA Analytics and QC related CAPA and Effectiveness Check items to completion and timely closing.
  • Ensure that documents are correct and adhere to SOPs and customer requirements.
  • Represent specific functional areas as QA Analytics Subject Matter Expert (SME) and provide guidance and recommendations in these areas to internal or external stakeholders.
  • Support and drive specific projects as well as revise and approve SOPs.
  • Support QC during regulatory inspections and customer audits.

Requirements

  • Academic degree in Chemistry, Biochemistry, Biotechnology, Life Science or related field.
  • Profound working experience in the pharmaceutical industry within QC/QA required.
  • Founded analytical expertise and experience with analytical method validation, change management, deviation management and Out of Specification (OOx) investigations.
  • Strong background in cGMP regulations, including USP, European and Japanese Pharmacopeia.
  • Auditing experience and experience in interaction with Health Authorities (FDA, Swissmedic).
  • Experience in working in cross-functional teams.
  • Excellent verbal and written communication in English required; German is advantageous.

Benefits

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • A variety of benefits dependent on role and location.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.
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