Quality Assurance Specialist

About the role

The Quality Assurance Specialist supports the QA Supervisor in overseeing and implementing the Marken Quality Management System (QMS), standard operating procedures, processes and policies for Marken's storage, distribution and transportation and kit production facility. The role ensures compliance with regional and local regulations and customer requirements, including GMP, GDP, GSP, ISO 13485 and ISO 9001.

Key responsibilities

• Maintain the company's quality systems in line with Marken's Global QMS and support clients on QA/GxP matters
• Run an internal audit schedule, including reports, CAPA tracking and oversight of vendor audits
• Support client audits and regulatory inspections, prepare materials and act as main representative when aligned with the QA Supervisor
• Manage issues and CAPA plans, track CAPA metrics, run quality improvement initiatives and ensure proper CAPA closure
• Identify GxP-related training needs and support change control and vendor evaluation
• Ensure accurate records, document quality and documented training for all personnel
• Coordinate recalls, attend quality meetings, update SOPs for regulatory changes and carry out device/equipment qualification and calibration in SAO branches
• Ensure the facility complies with local laws and authority regulations

Required profile

• Pharmaceutical or healthcare industry experience
• Bachelor's degree in a science-related field (or internationally comparable)
• Previous experience in Quality Management Systems
• Knowledge of local regulations
• Excellent written and oral communication, good interpersonal skills, organized and methodical
• Advanced English

Required skills

• Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice
• Quality Management Systems
• Microsoft Office