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QC Validation Manager m/f)

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QC Validation Manager m/f)

Do you have a sharp eye for precisely validating QC measures? Are you looking to take on new challenges? If so, we have a spot for you at Dynavax GmbH, a subsidiary of Dynavax Technologies Corporation, which is bringing HeplisavTM to the US market!
Your scope of duties:
You will take on analytical test method validation projects with a clear strategic focus. This includes the periodic re­view of validation test methods along with the planning of validation project capacities. You will manage the various measures of the validation teams with a steady hand while also preparing detailed validation protocols and reports and coordinating the corresponding validation report review and approval.
Moreover, you will be responsible for planning and implementing instrument qualification and computer systems validation projects. Here, you will ensure the GMP-compliant status of the instruments and computer systems in QC. Furthermore, you will provide support and advice to asset owners in qualification / validation.
You will work in collaboration with analytical development teams, site and corporate validation and automation ex­perts, and with corporate and site QA to achieve the best results for the entire company. Finally, you will represent the site as a member of global validation teams and report directly to the head of QC.
Your background:
  • You have an education in the life sciences, chemistry or pharmacology as well as at least 5 years of work ex­perience in biologics quality control
  • You have a profound knowledge of the regulatory requirements for analytical method validation, instrument qualification and computer systems validation as well as cGMPs for manufacturing and biologics testing
  • You have experience in project management and a variety of analytical techniques including, but not limited to, ELISA, SDS-PAGE, HPLC
  • You are familiar with the statistical evaluation of analytical results
  • You are fluent in both English and German and experienced in writing GMP reports in both languages
  • You possess good communication and interpersonal skills coupled with a proven ability to establish collabora­tive working relationships
  • You can manage multiple projects and tasks while working in a goal-oriented manner with high flexibility and integrity
Are you ready to work in a challenging, but also dynamic and growing environment?
Then submit your application and make a difference in a position that gives you room to grow. We offer a competiti­ve compensation package including benefits, a flat hierarchy and many opportunities for professional development. We look forward to hearing from you.
Please submit your application online..
Referenz: HP 165
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