Dynavax Technologies

  • Senior Specialist QA Batch Release (m/f/d)

    Job Locations DE-NW-Düsseldorf
    Job Post Information* : Posted Date 2 months ago(2 months ago)
    Req. #
    HP-230
    # of Openings
    1
    Category
    Quality Assurance
  • PRIMARY PURPOSE OF POSITION

    In this role, you will support the Quality Assurance organization at Dynavax Düsseldorf manufacturing facility. This role requires the successful candidate to:

    MAJOR DUTIES OF POSITION

    • Oversight and review all quality-related activities related to analytical data, environmental and water monitoring data
    • Support of QA Release of raw materials
    • Support for follow up of internal/external audits
    • Review of SOPs related to the complete process of generating analytical data, environmental and water monitoring data and certificates of analysis (transfer of analytical data of CofA)
    • Review of documents for QC standards
    • Compilation and Review of Batch Record Documentation
    • Support and review of QS documents (related to analytical data as (re)validation plans, (re)validation reports, risk analysis)
    • Issuance/Writing of SOPs
    • Issuance of controlled documents
    • Support CAPAs, Changes and Deviations management
    • Support investigations resulting from Deviations
    • Conducting of Self Inspections in the Laboratory
    • Support Archiving

    KNOWLEDGE AND SKILL REQUIREMENTS

    • Bachelor’s degree or higher in Biology, Chemistry, Engineering, Industrial Management, Operations, Quality, or Manufacturing (other degrees in combination with relevant experience acceptable) or equivalent experience in pharmaceutical industry
    • 5+ years of relevant work experience in Quality Assurance or in combination with relevant education.
    • Working knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and drug products.
    • Good understanding of cGMPs, industry and regulatory standards and guidelines
    • User skills in MasterControl is an advantage but not mandatory
    • Excellent interpersonal skills
    • Experience working with cross-functional teams
    • Strong ethical foundation and a sound compliance understanding
    • Business fluent in German and English

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