Quality Specialist (Analytical Data Review)

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.

Job Responsibilities

• Perform comprehensive review of batch records, GMP documentation (deviations, OOS, OOT, LIR, CAPA, Change Controls, validation reports, and COAs), ensuring completeness, accuracy, and compliance prior to batch release or rejection.
• Evaluate QC analytical data, audit trails, raw data, chromatograms, spectra, and results from laboratory systems (HPLC, GC, LIMS) to verify compliance with approved methods, specifications, and ALCOA+ data integrity principles.
• Review manufacturing and packaging activities against approved BMR/BPR, ensuring step-by-step procedure compliance and identifying deviations or discrepancies.
• Provide QA support on the production floor during manufacturing, investigations, and critical operations.
• Participate in investigations related to deviations, OOS, OOT, and quality events; ensure timely closure with appropriate root cause analysis and review of effectiveness checks.
• Review, approve, and monitor CAPAs to ensure corrective and preventive actions resolve root causes and prevent recurrence.
• Review validation documents (process, cleaning, and analytical method validation) and compile supporting data to confirm product validation status.
• Provide QA oversight for R&D product development, scale-up, and technology transfer activities, ensuring GMP compliance and supporting resolution of deviations during exhibit/validation batches.

Experience Level: 5-6 Years

Industry Experience: API Experience is required

Qualification: B.Pharm, Bsc / Msc in Chemistry

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!