Verantwortliche Person / Sachkundige Person Großhandel (m/w/d) nach § 52a AMG
Core
Ensuring proper operation of wholesale pharmaceutical trade and compliance with all applicable legal and GDP requirements.
Role type
Compliance & Quality Assurance Manager (Pharmaceutical Wholesale)
Builds
Quality assurance systems for wholesale operations
Domain
Pharmaceutical industry + Regulatory Compliance (GDP, AMG)
Deliverable
dashboards & analysis
Required skills
GDP principles, AMG and AM-HandelsV regulations, Quality Management systems, CAPA, Change Control, Recall processes, Risk assessment, Warehouse and distribution logistics
Preferred skills
Pharmaceutical degree, GDP training, Experience in pharmaceutical environment or GDP-regulated wholesale
Responsibilities
Implement and maintain quality assurance systems, Monitor compliance with AMG, AM-HandelsV and GDP, Approve and evaluate processes related to goods receipt, storage, delivery, returns, recalls and complaints, Decide on the disposal of rejected, recalled or withdrawn medicines, Coordinate and document key processes, Evaluate deviations and risks regarding drug safety and GDP status, Collaborate with authorities and internal functions
Seniority
Mid-Senior, hands-on IC
