Pharmakant/in
Core
Leading the pharmaceutical production area to ensure GMP-compliant manufacturing, storage, and process validation of medicinal products.
Role type
Senior manufacturing operations manager (pharmaceutical production)
Builds
Pharmaceutical products (medicinal products)
Domain
Pharmaceutical industry + GMP manufacturing
Required skills
GMP compliance, production planning and control, validation and qualification, deviation management (CAPA), change control, regulatory documentation, team leadership, process improvement
Preferred skills
Quality management, risk management, pharmaceutical product development, experience with regulatory inspections
Technologies
GMP documentation systems, validation tools
Responsibilities
Lead and organize the production team; Plan and control production; Ensure GMP-compliant manufacturing and storage; Create, review, approve, and update manufacturing instructions and GMP documents; Review and release manufacturing protocols; Ensure and accompany validation of manufacturing and cleaning processes; Participate in qualification of rooms, equipment, and suppliers; Manage deviations and implement CAPA measures; Handle complaints and returns related to manufacturing; Participate in self-inspections and regulatory inspections; Collaborate with Quality Management and Quality Control.
Seniority
Senior, hands-on IC with leadership responsibilities