ProPharma Group seeks a Quality Specialist to support GxP compliance and quality management activities across pharmaceutical and biotech programs. The role involves managing deviations, quality events, and corrective actions, plus supporting client audits and regulatory inspections.
Responsibilities
Maintain GxP compliance and support eQMS activities including Change Control and CAPAs
Develop, review, and approve Deviations and Quality Events; communicate root cause analysis
Coordinate audit and inspection preparations, manage CAPA responses, and track closure
Perform effectiveness checks on Deviations and Quality Events to assess CAPA efficacy
Collect, analyze, and report on quality data related to CAPAs, Deviations, and KPIs
Requirements
Bachelor's degree and/or minimum 2 years of Quality Assurance experience
Fluent English speaking and writing skills
Knowledge of GxP Quality Management Systems and eQMS platforms
Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
Experience handling Deviations, Quality Events, CAPAs, and Effectiveness Checks
Strong organizational, prioritization, and project management abilities
Excellent written and interpersonal communication skills
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