- Responsible for Preparation/Revision of document (URS, IQ-OQ-PQ documents, 21 CFR Part 11, Annex 11

assessment, Data Integrity (DI) Checklist, User List, Deskman, WI, SOP, TRG)
- Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations
- Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check.
- Responsible for quality compliance activities for laboratory instruments qualification and calibration.
- Summarize, review, and report the analytical Instruments qualification and calibration for further approval.
- Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures.
- Scheduled CSV / Instrument periodic review activity
- Ensure on time GDP in technical function with right first time (RFT) approach.
- Responsible for ensuring team compliance to EHS, Quality & Business policies
- Any other work given by management from time to time.




- Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team
- Technical expertise in Analytical instruments qualification, calibration, protocol preparation and QMS.
- Build cohesive team valuing team spirit
- Able to anticipate the implications and consequences of situations and take appropriate actions in the interest of Client as well as Cal Scientific without compromising quality.
- Clear thoughts and effective and crisp communication.
- M.Sc specializing in Chemistry/ M. Pharma with proven experience of min. 10 yrs. in Instrument qualification and calibration.
- In depth experience in Chromatography (HPLC, UPLC, GC), Spectroscopy (MS, FTIR, UV), Thermal techniques (DSC, TGA) and Particle size measurements.
- Expertise in analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS)
- Positive Knowledge of ICH guidelines and different global regulatory authorities.

📌 Walk-in || Team Leader Calibration Support (Mumbai)
🏢 Calscientific (india)
📍 Mumbai