Quality Analyst

At TAPI, we’re not just a company—we’re a community committed to advancing health from the core. As the world’s leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global pharmaceutical companies. With a legacy spanning over 80 years and a portfolio of more than 350 products, as well as custom CDMO services, we’re shaping the future of health worldwide. Our strength lies in our people—a team of over 4,200 professionals across 13 state-of-the-art facilities in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico, and India. Together, we innovate, solve problems, and deliver excellence. Join us and be part of a mission that transforms lives.

Key Responsibilities:

• Oversee and process change controls including generation, justification, impact assessment, modification, review, approval, and implementation
• Applies to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems, etc.
• Manage document workflows including generation, modification, review, approval, and archival.
• Includes SOPs, production records, test methods, protocols, reports, labeling, etc.
• Review and approve documentation for GMP equipment setup.
• Covers IQ, OQ, PQ documents for laboratory and production equipment.
• Track, trend, and report quality metrics for site, regional, and global reviews.
• As per SOPs, corporate standards, and regulatory requirements.
• Review and approve lifecycle documentation for GMP computerized systems
• Conduct gap assessments and update SOPs to align with regulatory and quality compliance requirements.
• Develop and monitor corrective action plans.
• Provide quality support to Regulatory Affairs for market authorization updates and changes.
• Review documentation including LIRs, OOS reports, and Change Controls.
• Investigate product quality complaints.
• Ensure resolution with CAPA and timely closure.
• Review, approve, and close laboratory investigations/events.
• Include CAPA implementation and effectiveness checks.
• Oversee maintenance and calibration activities for facilities, equipment, and critical systems (e.g., process water)
• Manage regulatory and customer audits.
• Includes communication, tracking, resolution of observations, and regulatory reporting.

The ideal candidate will have:

• Education: B.Sc. / M.Sc. in Chemistry or B.Tech/BE (Chemical Engineering) or B.Pharma

• Experience: Minimum 10 years of experience in a regulated pharmaceutical environment.

• Preferred Industries: API / Pharma.

Make Your Mark with TAPI

Your journey with TAPI is more than a job—it’s an opportunity to make a lasting impact on global health. If you’re ready to lead, innovate, and inspire, we’re excited to welcome you to our team. Together, let’s shape the future of pharmaceuticals. Apply on top of this page and our talent acquisition team will be in touch soon!