Quality Specialist in India, भारत

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