QA Manager Ibex®

QA Manager Ibex®

Lonza

Visp, Switzerland

Key accountabilities and duties

  • Owns all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply;
  • Represents QA in project/tech transfer organizations for new biotech manufacturing processes;
  • Coordinates QA interests during the different project phases;
  • Has the authority to make quality decisions for the respective projects in internal and external meetings;
  • Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.;
  • Performs assessments for all product-related changes, assesses relevance to regulatory filings, decides to implement and provide change controls for approval to customers where required;
  • Supports and approves project/product specific risk assessments;
  • Performs internal and external audits;
  • Supports and participates in customer audits and health authority inspections;
  • Ensures all deviations are appropriately investigated and recorded;
  • Directs the investigations of customer product complaints and assures the completion of the appropriate documentation;
  • Responsible to drive CAPA and effectiveness check items to completion and timely closing;
  • Ensures an efficient cGMP compliant life cycle management of all products manufactured;
  • Identifies emerging QA relevant topics, communicates to the IBEX QA organization and works actively on their development into new or already established Quality and Compliance strategies and/or standards;
  • Supports cGMP training programs to ensure staff is being trained;
  • Trains and mentors junior Lonza employees to better accomplish and perform in their duties as quality professionals;
  • Actively supports the Quality culture as a role model.

Qualification and Skills required

  • Bachelor, Master degree or PhD in Chemistry, Biotechnology, Life Science or related field;
  • 5 years of experience in the GMP regulated pharmaceutical industry; preferable in a QA role;
  • Strong background cGMP regulations;
  • General knowledge of manufacturing processes and analytical methods;
  • Auditing experience;
  • Experienced in the interaction with health authorities (Swissmedic, FDA etc.);
  • Solution-oriented; Strong fact based decision maker;
  • Ability to oversee project execution to identify non-compliance from quality standards;
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment;
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive;
  • Strong team orientation;
  • Excellent verbal, written and interpersonal communication skills.

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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