Qualification Specialist (f/m/d)

Responsibilities

• Planning, execution, and documentation of qualifications (IQ/OQ) and calibrations of laboratory and production equipment in accordance with GMP, ISO, and GxP requirements
• Performing qualifications, particularly in regulated production environments and in cleanrooms of classes ISO 7/8
• Contributing to the preparation, maintenance, and optimization of quality-relevant documents such as qualification plans, reports, and SOPs
• Supporting the implementation of new equipment-from requirement definition through design and commissioning phases to successful qualification
• Supporting and contributing to risk analyses for the risk-based determination of qualification requirements
• Close cross-functional collaboration with Quality Assurance, Production, Development, and Engineering to ensure a high level of compliance and quality
• Supporting the preparation for audits and representing the department during regulatory inspections, as well as handling resulting actions

Requirements

• Successfully completed vocational training in a pharmaceutical, chemical, scientific, or technical field
• Basic knowledge of relevant standards and regulations in the area of qualification and calibration, e.g. GMP guidelines, DIN EN ISO 17025, ISO 13485
• Experience in the preparation or processing of qualification and/or calibration documentation in a regulated environment
• Proficient in MS Office, ideally with initial experience in ERP systems and document management systems, e.g. MasterControl
• Good written and spoken German and English skills
• ‎ ‎
• Freudenberg Medical Hemoteq GmbH

Additional Information

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