Corporate in Pharma & Life Sciences Sector Verified employer
Actively hiring · Posted 14d ago · JEV26104C1FB35D82
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)
Good Knowledge of ICH guidelines and different global regulatory authorities.
Role: Other,
Industry Type: Pharmaceutical & Life Sciences,
Department: Other,
Employment Type: Full Time, Permanent
Role Category: Other
