Senior Manager Qualification & Validation (m/f/d)

Professional responsibility for qualification and validation including planning, implementation, documentation and lifecycle management Qualification of plants, laboratory and production equipment Compilation of qualification documents including URS, risk analyses, DQ, IQ, OQ and PQ incl. practical implementation Planning, implementation and documentation of validation or Verification of analytical methods focusing on pharmaceutical and radiopharmaceutical test methods Planning and implementation of process validations and verifications Assessment of changes and deviations and definition of appropriate requalification, revalidation and monitoring measures Accompanying the procurement, installation and GMP-compliant commissioning of new plants and equipment Continuous development and innovation of the QV system

Successfully completed technical, scientific, pharmaceutical or comparable university studies Multiannual experience in qualification and/or validation in a regulated environment Knowledge of plant and equipment qualification including practical experience with IQ, OQ and PQ activities Experience with validation or Verification of analytical methods and ideally with process validations Experience in radiopharmacy, sterile drug production or with automated or shielded production systems Structured, independent and solution-oriented working methods as well as pronounced interdisciplinary cooperation Standing for stand-alone hand-on execution Innovation joy and openness to digital laboratory and quality systems such as LIMS, QMS and databases Flowing German knowledge (min. B2) and good English knowledge in word and writing

Flexibility: design of working hours through mobile work, flexible working hours and decent-related paid allowances (e.g. moving or dates for cancer provision) for an optimal work-life balance Family-friendliness: support in the reconciliation of family and profession, through paid allowances for family events, such as child-hospitable days, family start time or your own wedding Compensation package: Attractive remuneration as well as asset-effective services and property vouchers or JobTicket Holiday and recreation time: 30 days holiday for regular rest and to recharge energy Work comfort: pleasant work environment without large-scale office and ergonomic tables and chairs for comfort at work Stability & Perspective: Safe workplace in an established company with long-term prospects and development opportunities Health promotion: occupational health management with health insurance Variety of mobility: JobTicket, e-bike leasing, good ÖPNV connection and parking opportunities for sustainable mobility