Senior Executive/ Dy. Manager – Analytical Development(mAbs)

Job Description

We are Hiring | Senior Executive/ Dy. Manager – Analytical Development(mAbs) Role and Responsibility – Senior Executive: (03 to 07 Years Exp) • Candidate should have good technical knowledge on chromatography/electrophoresis techniques • Candidate should have method development experience chromatography/electrophoresis techniques • Candidate should have handling experience on Method Qualification as per ICH guidelines. • Perform calibration and preventive maintenance and qualification of instruments as per the schedule. • Coordination with Aragen cross functional teams to meet the qualification milestones. • Preparation of department documents like SOP’s, STP’s, MOA’s, protocols and reports etc. • Perform the analysis and its online documentation and Ensure in every activity adhere to Data integrity policy. Role and Responsibility – Deputy Manager: (08 to 10 Years Exp) • Candidate should have QC QMS handling experience • Candidate should have handling experience on Change Control, Deviation, CAPA, Investigation and Timely closure of QMS • Candidate should have handling experience in chromatography technique and it’s troubleshooting. • Candidate should have prior experience on Equipment qualification (URS,IQ,OQ,PQ) • Track Equipment PM / AMC / calibration and ensure it is done timely manner • Ensure the Lab is comply with established procedures • Sample management compliance • Stability planner / withdrawals and compliance • Internal audit representative • Review of equipment and other lab logbooks Interested can connect with prashanth.cherugad@aragen.com