Senior QA Officer

. The Sr QA officer ensures compliance with regulations and local procedures.

Main activities

o   Quality Management System

Support, maintenance and improvement of the Quality Management System and the processes within the QMS

o   Quality support

Review and approve Quality Records and Quality Documents against internal procedures and GxP laws and regulations.

SME on the processes of deviation, CAPA, change control and documentation.

Review and approve stability plans and reports and master documents for the manufacturing and testing.

o   Compliance with regulations, qualification and audit support

Conduct audits of various internal departments and external suppliers.

Maintain and improve inspection readiness.

o   Training, development and coordination

Provide training to employees within the organization in the field of quality and GxP

Oversight of TMS, maintain and improve training structure for the company.

Coaching of (junior) QA officers and employees

o   Operational readiness and project support.

Review and approve qualification and validation documentation for facilities, utilities, equipment, assays and processes.