Quality Assurance System Specialist

About the role

Labatec Pharma is seeking a Quality Assurance System Specialist to join its QA team. The role focuses on maintaining, overseeing, and continuously improving the Pharmaceutical Quality System (PQS) to ensure compliance with GMP, regulatory requirements, and internal procedures.

Key responsibilities

• Manage the lifecycle of SOPs, policies, forms and quality documents, ensuring periodic review and document control.
• Administer GMP/quality training systems and verify personnel are trained before performing activities.
• Conduct internal audits and self‑inspections across GxP areas, and follow up on CAPA plans.
• Assess quality/regulatory impact of changes, approve, implement and close them.
• Oversee deviation processes, perform investigations, root‑cause analysis and verify CAPA effectiveness.
• Apply risk assessment tools and integrate Quality Risk Management (QRM) into processes.
• Establish, monitor and report quality KPIs and trends to management.
• Manage electronic QMS, including workflows, access, data integrity and system improvements.
• Promote a culture of continuous improvement and high quality standards.

Required profile

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering or a related scientific field.
• 3–5 years of Quality Assurance experience in the pharmaceutical industry, preferably in a GMP manufacturing environment.
• Strong knowledge of EU GMP/GMP requirements and pharmaceutical quality systems.
• Experience with internal, supplier and regulatory audits/inspections.

Required skills

• EU GMP / GMP compliance
• Quality Management System (QMS) and Electronic QMS (eQMS) expertise
• CAPA management
• Change control processes
• Quality risk assessment
• Root cause analysis
• Audit management
• SOP and document lifecycle management