Quality Control Analyst
1 week ago
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 Main Responsibilities 1 24 x 7 audit readiness 2 Participation in internal external regulatory audits 3 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 7 Follow up the housekeeping cGMP GLP and Safety Guideline in laboratory 8 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 9 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 Qualifications The ideal candidate will have Education M Sc in Chemistry Experience Minimum 8 years of industrial experience Preferred Industries API Pharma 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
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