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 that control storage, distribution and transportation and the 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 the 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 respond to audit reports
• Manage CAPA plans, track CAPA metrics, run quality improvement initiatives and ensure CAPA close-out
• Identify GxP-related training needs and support change control
• Ensure accurate records and documents, monitor training, coordinate recalls and attend quality meetings
• Stay up to date on regulatory changes and update SOPs where needed
• Carry out qualification activities and device/equipment calibration in SAO branches, and ensure the facility complies with local laws

Required profile

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

Required skills

• Knowledge of GMP, GSP and GDP guidelines
• Proficiency in Microsoft Office
• Advanced English