Quality Control Analyst
2 days ago
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.
Main Responsibilities:
x 7 audit readiness.
Participation in internal, external, regulatory audits.
Ensure 100% participation in training's against CAPA's.
4. Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge.
5. Supporting to share required documents from QC to RA/ other requirement.
6. Determining team priorities in accordance with the plant's needs, while coordinating with the team leader /Manger.
Follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory.
Sampling and analysis of RM / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms.
Perform analytical test according to the monograph and SOP.
10. Responsible for calibration and verification of instruments.
11. Responsible to work in shift as per requirement.
12. Maintaining of reserved samples room and chambers / autoclaves / incubators.
13. Help in preparation of documents related to department (like STP's, SOP's and etc.)
14. Ensure the sampling of finished products, Raw material, Intermediate and sending sample to outside laboratory for analysis.
15. Must be ensured sampled, approved and rejected labels timely as required.
16. Responsible to maintain the stock record of chemicals and reconciliation of standards.
17. Responsible to maintain safety CAPA.
18. Responsible to maintain 5-S in QC.
19. Online documentation (based on requirement) must be ensured as per data integrity norms and awareness to team against data integrity.
20. Responsible to support analysis reduction/QC efficiency enhancement programs.
21. Any other job assigned by the Manger - QC Manger or group leader - QC
Preferred Skills:
Preferred experience with Wet lab instruments/techniques including but not limited to Karl Fischer Titrator, Auto-titrator, analytical balance, FTIR, Polarimeter, UV, X-ray Diffraction, etc.
QualificationsThe ideal candidate will have:
Education: M.Sc. in Chemistry.
Experience: Minimum 8 years of industrial experience.
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
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