Spezialist in der Qualifizierung und Softwarevalidierung (Mensch)

Lamm HR GmbH is seeking a Spezialist in der Qualifizierung und Softwarevalidierung (Mensch) for a pharmacy industry client in Landkreis Bergstraße, Hessen, Deutschland. This entry-level position is suited for candidates with 0 to 2 years of experience holding a bachelor's degree in pharmaceutical engineering, chemical engineering, or a technical education with relevant advanced training such as a technician qualification for pharmacy or chemical plant operators.

Anforderungen und Aufgaben

• Ensuring existing pharmaceutical production systems meet GMP guidelines, including filling systems, pure media systems, and autoclaves.
• Handling recurring evaluations, annual requalifications, audit trail reviews, and documentation.
• Developing User Requirement Specifications (URS), creating risk analyses like FMEA, and writing standard operating procedures (SOPs).
• Managing change control requests, deviations, CAPAs, and supporting audits and GMP-compliance optimization.
• Bringing experience in computer software validation, solid GMP knowledge, structured working methods, and strong German alongside good English skills.

Arbeitsumfeld und Benefits

The role offers market competitive compensation complemented by company pension schemes, supplementary health insurance, meal allowances, and corporate benefits. Employees benefit from a friendly team environment in the pharmacy sector, partial home office options, modern workplaces, ongoing professional development opportunities, on-site parking, and free water and coffee.