In this role, the QA Specialist in Qualification will ensure quality assurance for new pharmaceutical facilities. The specialist will collaborate with project teams to ensure compliance with regulatory standards, guiding qualification strategies. Key responsibilities include representing QA in qualifications, coordinating QA interests, compiling qualification documents, and assessing technical change requests. 

Start Date: 01/06/2025

Duration: 6 Months

Key Responsibilities

  • Act as the QA Qualification representative within project teams for new facilities and projects, ensuring compliance in the qualification of facilities, utilities, equipment, and systems
  • Coordinate and align diverse QA interests throughout the project lifecycle, including processes and cleaning strategies
  • Drive the execution of a new qualification strategy, making informed decisions as necessary
  • Compile, review, and release essential qualification documents such as URS, Qualification Plans & Reports, and DQ/IQ/OQ/PQ Reports while supporting quality risk analysis (e.g., FMEA)
  • Conduct assessments and approve technical change requests relevant to the qualification of various systems and equipment during different project phases
  • Represent qualification aspects during audits by customers and regulatory bodies
  • Lead CAPA initiatives and Effectiveness Checks to ensure timely resolution and appropriate documentation of deviations in Deviation Reports

Candidate Profile

  • Bachelor’s degree in Engineering, Chemistry, Biotechnology, or a related discipline
  • Extensive experience in qualification processes within the pharmaceutical industry
  • General knowledge of engineering and manufacturing processes
  • Proven ability to monitor project execution and identify non-compliance with quality standards
  • Strong understanding of applicable cGMP regulations is advantageous
  • Languages: Fluent in German & English

 

Job ID 41180445