Walk-in | Team Leader Calibration Support

Calscientific (india); Mumbai; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Calscientific (india) seeks a senior professional to lead instrument qualification and calibration programs in a GMP/GLP-compliant environment. You will coordinate with lab supervisors, manage CAPA and QMS activities, and drive adherence to regulatory standards across analytical instrumentation.

The role requires extensive hands-on experience with chromatography, spectroscopy, and thermal techniques, along with strong communication and team leadership skills.

Qualifications

• M.Sc or M.Pharma with 10+ years in instrument qualification and calibration.
• Hands-on experience with chromatography, spectroscopy, thermal analysis and particle sizing.
• Strong knowledge of ICH guidelines and global regulatory requirements.

Responsibilities

• Prepare/revise URS, IQ-OQ-PQ, 21 CFR Part 11, Annex 11 assessments.
• Coordinate with lab supervisors for non-conformances or escalations.
• Manage CAPA, deviation investigations and other QMS activities.
• Qualify/calibrate instruments; summarize and report qualifications.
• Guide subordinates in laboratory procedures and maintain discipline.
• Schedule CSV/instrument periodic reviews; ensure GDP with RFT.
• Ensure compliance to EHS, Quality & Business policies.

Skills

Instrument qualification

Calibration

Protocol preparation

QMS

Team leadership

Education

M.Sc in Chemistry

M.Pharma

Tools

HPLC/UPLC/GC

Mass spectrometry

FTIR/UV spectroscopy

DSC/TGA

Job description

• 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.