Qualification Specialist (f/m/d)
On-site · Würselen, North Rhine-Westphalia, Germany
Job Summary
Qualification Specialist responsible for planning, executing, and documenting IQ/OQ qualifications and calibrations of laboratory and production equipment in accordance with GMP, ISO, and GxP requirements. Responsibilities include maintaining qualification plans, reports, and SOPs; supporting implementation of new equipment from requirement definition to commissioning and qualification; contributing to risk analyses for qualification requirements; collaborating cross-functionally with Quality Assurance, Production, Development, and Engineering to ensure compliance; assisting in audits and regulatory inspections and addressing resulting actions. Proficiency in German and English, experience with GMP/regulatory environments, and exposure to ERP and document management systems are desired.
Required Qualifications
- Vocational training in a pharmaceutical, chemical, scientific, or technical field
- Basic knowledge of GMP guidelines, DIN EN ISO 17025, ISO 13485
- Experience in preparing or processing qualification and/or calibration documentation in a regulated environment
- Proficient in MS Office, ideally with ERP systems and document management systems (e.g., MasterControl)
- Good written and spoken German and English skills
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