SPS BE QA Manager

Position

• Drives site cGMP compliance: determine, enforce and maintain the required cGMP level
• Takes appropriate actions in cases of non-compliances observed
• Ensures that relevant MSOP’s, SOP’s, WRKI’s and other instructions and documents are kept
  up-to-date and aligned with EU requirements and global policies, where applicable
• Keeps Quality Agreements with customers up-to-date
• Ensures Manufacturing authorization, GMP licenses, ISO 13485 and other required licenses and certificates regarding medicinal products, medical devices and other products manufactured at Sharp BE are kept up-to-date
• Ensures site hygienic and gowning requirements are adequate
• Guides and Leads customers audits and audits by health authorities and certifying bodies
• Organizes and leads Quality Management Reviews
• Sets up, monitors and improves Quality Key Performance Indicators
• Manages the internal and external (suppliers) audit schedules
• Approves Annual Product Reviews and ensures these are reported timely
• Manages timely documentation and responses to customers and authorities (batch records, validation reports, etc.)
• Manages quality improvements and CAPA systems
• Manages customer complaints
• Manages the QA department of Sharp Belgium.
• Coaches and evaluates team members
• Provides support and pragmatic solutions to the operations department and other departments as appropriate
• Acts as site responsible for QA and RA matters by:
  • Ensuring the correct working of the quality management system
  • Assuring and maintaining the cGMP level
  • Managing the Quality Assurance and Regulatory Affairs department
  • Managing the interfaces with customers and health authorities regarding quality and regulatory topics
  • You also act as the local head of the quality control

Profile

• Master degree (minimum) preferably in pharmacy or life science.
• Completed with relevant training and courses.
• Fluent in Dutch and English. French is a pro.
• Minimum 5 years of experience within relevant QA/RA positions in the pharmaceutical industry.
• Knowledge on Quality systems & cGMP Pro-active
• Motivator and leader
• Excellent planning and organizing skills
• Attention to detail
• Thinks in processes and solutions
• Result driven and a commercial mindset