The role is responsible for leading compliance efforts including the review and approval of all master documents such as SOPs and batch manufacturing records
Job Summary
The role is responsible for leading compliance efforts including the review and approval of all master documents such as SOPs and batch manufacturing records.
Candidates must ensure 100% safe operations in production areas while maintaining strict adherence to GMP regulations and environmental management systems.
The position requires effective coordination with cross-functional teams to drive continuous improvement projects and resolve issues through daily interactions.
Matching Summary
The role is responsible for leading compliance efforts including the review and approval of all master documents such as SOPs and batch manufacturing records.
Skills & Requirements
Must-have
GMP regulatory compliance expertise
Master document review and approval
CAPA investigation and closure
Change control execution and management
Production planning and resource utilization
ISO14001 and ISO45001 environmental safety
Team leadership and coaching
Nice-to-have
Continuous improvement project experience
Cross-functional team coordination skills
SAP system training and control
Process capability studies knowledge
Risk assessment methodology
Culture of excellence implementation
Key Requirements
Experience in medical device manufacturing
Knowledge of cGMP and QMS compliance
Leadership experience in manufacturing environments