Validation and Qualification Specialist | Specialist Validerung und Qualifizierung (w/m/d)
Stada Arzneimittel AG
Job Summary
As a Validation and Qualification Specialist at STADA Arzneimittel GmbH, you will join a motivated team dedicated to maintaining high standards within a GMP-regulated pharmaceutical environment. Your daily responsibilities involve creating and managing critical documentation such as User Requirement Specifications (URS), Risk Assessments, and DQ/IQ/OQ/PQ protocols. You will play a pivotal role in project teams, overseeing equipment qualification, cleaning validation, and the monitoring of calibration and maintenance schedules. Beyond documentation, you will evaluate deviations, manage Change Controls and CAPAs, and support periodic reviews. This role is highly collaborative, requiring close coordination with Engineering, IT, Quality Assurance, and external service providers. It is an excellent opportunity for a professional looking to deepen their expertise in regulatory compliance and technical system validation while preparing for and supporting internal and external audits.
Required Skills
Education
Degree in Engineering, Natural Sciences, Pharmacy, or a comparable qualification.
Experience
- Professional experience in qualification and validation within a GMP-regulated environment
- Experience handling technical equipment, laboratory systems, or production systems
- Experience in creating, reviewing, and maintaining regulatory documentation
- Experience managing deviations and CAPA processes
Languages
Additional
- Not specified