Quality Assurance System Specialist
About the role
Manage the lifecycle of SOPs, policies, forms, and quality documents; ensure periodic review and document control. Manage GMP/quality training systems, ensuring personnel are properly trained. Conduct internal audits and self-inspections across GxP areas, following up on CAPA plans. Ensure changes are assessed for quality/regulatory impact, approved, implemented, and closed. Oversee deviation processes, investigation quality, root-cause analysis, and CAPA effectiveness. Ensure proper use of risk assessment tools and QRM integration. Establish and monitor quality KPIs, trends, and reporting to management. Manage the electronic QMS and related systems (workflows, access, data integrity, improvements). Champion continuous improvement and high quality/integrity standards.
Requirements
- Bachelor's or Master's in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, Engineering, or related field
- 3-5 years in QA within the pharmaceutical industry, ideally GMP manufacturing
- Strong knowledge of EU GMP requirements and pharmaceutical quality systems
- Experience with QMS/eQMS, deviations, CAPA, change controls, and risk assessments
- Experience with SOP and document management
- Experience supporting internal, supplier, and regulatory audits/inspections
- Good grasp of root-cause analysis methodologies
- Experience with quality metrics and trend identification
- Strong analytical, organizational, and problem-solving skills
- Fluent English; French a plus
- Proficient in MS Office; eQMS platform experience a plus
What we offer
- Collaborative, friendly environment at a human-sized company
- Established company operating with agility
- Continuous professional training
- Rewarding compensation and benefits package