QA Sterile DP Specialist

Job Type
Emp Type
Full Time
Functional Expertise
Quality Assurance
Salary Type

Job Description

    QA Product Specialist (Sterile DP)

      • Acts as first contact person for manufacturing projects for quality and compliance aspects.
      • Act as liaison to the customers, participate at customer meetings and informs with respect to quality topics.
      • Ensures QA Coordination in Tech Transfer Processes
      • Review and approves process related and analytical change requests of the product cluster.
      • Reviews and approves stability protocols and reports
      • Reviews and approves specifications for Drug Product/Drug Substance.
      • Reviews and approves Master Batch Record in alignment with registration
      • Overviews and ensure progress of quality records and batch record review for assigned products in relation with batch release.
      • Reviews and negotiate Quality Agreement with customer.
      • Reviews and approves investigated and completed customer complaints
      • Ensures communication with customer with respect to complaint management
      • Ensure that Quality Agreements are followed.