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Jacobs CQV Lead 
Denmark, Capital Region of Denmark 
90214664

17.08.2024
Your impact

Responsibilities include:

  • Provide Quality management and oversight of the design and qualification activities;
  • Develop and maintain the project quality activity plan;
  • Drive the quality activities during the project execution phase from requirement setting, design through construction, verification and system release for process validation;
  • Supporting the science and risk-based qualification and validation activities and agreeing best practices in line with applicable GMP Regulations;
  • Support the execution and reporting of the commissioning, qualification, and validation activities;
  • Prepare or review all documentation where required specific to quality activities;
  • Ensure any deviations are thoroughly investigated and closed in a timely manner;
  • Train project members in science and risk-based approach to validation.
Here's what you'll need
  • Significant experience from a similar position within project execution the pharmaceutical or life-sciences industry;
  • Strong experience with Commissioning, Qualification and Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility;
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500;
  • Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15;
  • Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products;
  • Track record of utilizing Risk Based Approaches to Qualification / Validation activities;
  • Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.