Spezialist in der Qualifizierung und Softwarevalidierung (Mensch)

Spezialist in der Qualifizierung und Softwarevalidierung (Mensch) in Landkreis Bergstraße

Lamm HR GmbH is seeking an entry-level Spezialist in der Qualifizierung und Softwarevalidierung (Mensch) for a pharmaceutical client in Landkreis Bergstraße, Hessen, Deutschland. This pharmacy field role is suitable for candidates with 0-2 years of experience and a Bachelor's degree, such as a degree in Pharmaceutical Engineering or Chemical Engineering, or a technical education with relevant advanced training (such as Pharmakant or Chemikant with technician training).

Anforderungen und Aufgaben

In this role, you will ensure that existing production systems such as filling lines, pure media systems, and autoclaves comply with GMP regulations. Your responsibilities include handling recurring evaluations, annual requalifications, audit trail reviews, planning and documenting qualifications, developing URS, conducting risk analyses, and writing SOPs. You will also manage deviations, change control requests, CAPAs, and support audits.

• Completed degree in Pharmaceutical or Chemical Engineering, or technical training with advanced qualification
• Experience in pharmaceutical production with solid knowledge of GMP compliance and qualification systems
• Experience in computer software validation
• Expertise in audit trail reviews, URS creation, and risk analyses like FMEA
• Proficiency in MS Office alongside very good German and good English skills

Arbeitsumfeld und Benefits

The position offers market competitive salary alongside company pension and supplementary health insurance. Employees benefit from a good work-life balance with partial remote work options, friendly colleagues in small teams, flat hierarchies, and continuous training opportunities. Additional perks include free coffee and water, a meal allowance, corporate benefits, and on-site parking.