Tejal Naik
MSAT expertise
- Role
- Senior Executive at Biocon
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Tejal Naik
Senior Executive with 4+ years experience in manufacturing of bio-similars. Experience in…
Experience
Senior Executive
May 2021 — Present · Bengaluru, IN
Operation Compliance, QMImplementation of Quality management system (QMS): ChangeManagement System comprisingChange Control, Corrective and Preventive Action (CAPA), Risk Assessment, Impact Assessmentpreparation, Deviation Management System, Investigation of Deviations.Maintaining records on Trackwise, executing open actions, receiving and reviewing responses,working with functional departments for timely completion of targets complying with effectiveperiodic reportingEquipped with skills in Good Manufacturing practices and Good Documentation Practices withemphasis on Quality assurance.Preparation of Standard Operating Procedures and Batch Manufacturing Records, protocolsand reportsReview of executed BMRs of upstream processing for production of Monoclonal antibodiesutilizing mammalian cell cultures, qualification and validation protocols along with addressal of anyGDP related queries by following ALCOA+ policy and GMP.Involving in qualification and re-qualification activities and reviewing the qualification documents. Review of Consumption based planning and requirements recorded in SAP.
Education
Reliance Institute of Life Sciences (RILS)
Advance diploma in Biotherapeutics
2015 — 2016
DY Patil University
Bioinformatics
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