Senior Specialist, Operations (m/w/d)
Core
Ensuring GMP, EHS, and compliance requirements in a biopharmaceutical manufacturing facility for animal health products.
Role type
Senior Specialist, Operations (Quality & Compliance)
Builds
High-quality solid dosage forms (tablets, granulates, implants) for export markets.
Domain
Life Sciences / Biopharmaceuticals / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, EHS compliance, Quality Risk Management (QRM), Change Control management, Deviation investigation, SOP management, Process optimization, Stakeholder coordination, Project management
Preferred skills
Process engineering background, Lean Six Sigma, Project management methodology
Technologies
eLogs systems, GMP/EHS regulatory frameworks
Responsibilities
Lead and coordinate Change Controls and Quality Risk Management activities; Investigate and resolve deviations; Ensure audit readiness and compliance; Optimize bulk manufacturing processes; Develop and update SOPs; Conduct training on GMP and EHS topics.
Seniority
Senior, hands-on IC
