Specialist, Planning & Scheduling (m/f/d)
Core
Manage and support quality-related and technical activities in a GMP-regulated pharmaceutical manufacturing environment, including investigations, documentation, and continuous improvement.
Role type
Specialist, Planning & Scheduling (Quality & Technical Support)
Builds
Inspection-ready operations and compliant process/system changes for global clinical trial medicines and vaccines.
Domain
Biopharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Deviation management, Change control, CAPA implementation, SOP creation, Calibration, Validation, Qualification, Root-cause analysis, Quality risk assessment, GMP compliance, Six Sigma, SAP, ProCal, eVal, DeltaV, Veeva Vault, MEDS, eShop Floor
Preferred skills
Life Sciences degree, GMP-regulated environment experience, Technical problem-solving, Cross-functional collaboration, English fluency
Responsibilities
Own and coordinate deviation records, Support and monitor change control activities, Create and maintain SOPs and GMP documentation, Execute calibration, validation and qualification activities, Investigate technical issues and perform root-cause analyses, Perform quality risk assessments, Partner with cross-functional stakeholders for audits and inspections, Contribute to improvement projects, Support Environmental Health & Safety activities
Seniority
Mid-level, hands-on specialist