Company Description
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 Description
We are looking for a proactive Quality Control (QC) Technician with strong hands-on experience in HPLC analysis, analytical testing, and laboratory operations. If you can operate in a multi-shift environment, maintain 24×7 audit readiness, and have experience in LIR/OOS/OOT investigations, instrument calibration, and GMP/GLP compliance, this opportunity in a pharmaceutical setup is ideal for you.
Key Responsibilities
- Perform analysis of raw materials, intermediates, finished products, stability samples, and cleaning samples using HPLC as per approved monographs, test methods, and SOPs, ensuring accurate and timely result reporting in analytical records, LIMS, and QA documentation in line with data integrity requirements.
- Carry out routine operation, calibration, system suitability checks, and maintenance of HPLC systems, including troubleshooting of chromatographic issues to ensure consistent performance and compliance.
- Prepare mobile phases, standard solutions, and test samples; ensure proper sampling, labeling (approved/rejected), and handling of samples with full traceability and documentation.
- Maintain laboratory equipment, working areas, and controlled environments (sample rooms, chambers, etc.) in compliance with cGMP, GLP, and safety standards.
- Support preparation, review, and revision of SOPs, STPs, analytical methods, and other QC documentation in coordination with cross-functional teams.
- Monitor and maintain inventory of chemicals, reagents, columns, and reference standards with proper stock reconciliation.
- Initiate, investigate, and document LIR, OOS, OOT, and atypical/borderline results; assist in root cause analysis and implementation of CAPA.
- Maintain data integrity through proper electronic records management, secure data entry, and adherence to 21 CFR Part 11 requirements; ensure continuous 24×7 audit readiness by adhering to regulatory requirements.
- Support instrument qualification activities including IQ/OQ/PQ protocols and assist in analytical method validation studies and method transfer activities.
- Work in rotational shifts as required, complete all assigned training programs, ensure full compliance with CAPA-related actions, and maintain high standards of housekeeping and safety within the laboratory.
Qualifications
The ideal candidate will have:
- Education:B.Sc. / M.Sc. in Chemistry or B.Pharma.
- Experience:Minimum 3 to 4yearsof industrial experience.
Additional Information
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!
