Quality Control Associate - LIMS

Hands-on experience in LIMS master creation, revision, and review support Knowledge of specifications, sample plans, test methods, calculations, inventory, schedules, reagent masters, and stability masters.

Understanding of LIMS workflow configuration, approval workflows, and audit trail requirements.

Experience in challenge testing and verification of configured masters against approved source documents Understanding of QC analytical, microbiology, stability, raw material, packing material, and bioassay testing processes.

Familiarity with specifications, STPs, methods, protocols, and laboratory workflows.

Knowledge of analytical techniques such as HPLC, UPLC, TOC, BET, CE-SDS, HCD, HCP, particle count, and environmental monitoring Ability to interpret SOPs, Work Instructions, Specifications, Forms, Validation Reports, Qualification Protocols, and JOS documents.

Understanding of change controls, deviations, CAPAs, OOT/OOS requirements, and audit trail review expectations.

Educational qualification: An M.Sc., or B.Tech. in Biotechnology, Microbiology, Biochemistry, Minimum work experience : 3+ years Skills & attributes: Technical Skills 1) Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends. 2)Hands-on experience in LabWare LIMS master data creation 3)Ability to do process mapping of a procedure. 4)ability to identify gaps in the existing process flows. 5)Design, create master data and execute dry runs for verification. 6)Effective communication with end users, CFT’s, line QA regarding the master data. 7)Design logics and verification through dry runs. 8)Execution of test scripts to enable qualification of instruments, new modules as per process flows.

Behavioural skills • Prioritizes effective communication and demonstrates a performance-oriented mind-set.

•Effective verbal and written communication skills.

•Performance-oriented approach, consistently striving for high standards.

•Demonstrates flexibility in working shifts and a clear understanding of team dynamics.