Senior Executive

Sentiss Pharma Pvt. Ltd.; Himachal Pradesh; Presencial; INR 420.000 - 680.000; Jornada completa

Descripción de la vacante

Sentiss Pharma Pvt. Ltd. is seeking a QC Analyst with hands-on experience in instrument calibration and regulatory compliance.

The role requires meticulous record keeping for HPLC, GC, UV, Autotitrator, KF, Mastersizer, and related equipment. The ideal candidate will possess strong knowledge of Schedule L, Schedule M, 21 CFR Part 11, EU Annexure 11, Data Integrity, and ICH guidelines, with experience in investigations, deviation management, and SOP development.

Formación

• Calibration and record management of HPLC, GC, UV, Autotitrator, KF, Mastersizer, and other lab equipment.
• Strong understanding of Schedule L, Schedule M, 21 CFR Part 11, EU Annexure 11, Data Integrity, and ICH guidelines.
• Experience handling OOC, laboratory incidents, deviations, and preparing SOPs.
• Knowledge of working standard preparation, reference standard management, and procurement.
• IQ, OQ, and PQ preparation and execution.
• QC analyst qualification processes.

Responsabilidades

• Instrument calibration and record management for equipment like HPLC, GC, UV, Autotitrator, KF, and Mastersizer.
• Maintain regulatory knowledge including Schedule L/M, 21 CFR Part 11, EU Annexure 11, data integrity, and ICH guidelines.
• Handle investigations of OOC, laboratory incidents, deviations and prepare SOPs.
• Manage working standards, reference standards, and procurement.
• Plan and execute IQ, OQ, and PQ validation activities.
• Oversee QC analyst qualification processes and related documentation.

Conocimientos

Instrument Calibration

Regulatory Knowledge

Investigations

Standards Management

Validation

QC Analyst Qualification

Herramientas

LIMS

ERP software

Descripción del empleo

Role & responsibilities

• Instrument Calibration: Skilled in calibration and record management of HPLC, GC, UV, Autotitrator, KF, Mastersizer, and other laboratory equipment.
• Regulatory Knowledge: Strong understanding of Schedule L, Schedule M, 21 CFR Part 11, EU Annexure 11, Data Integrity, and ICH guidelines.
• Investigations: Experience handling OOC (Out of Control), laboratory incidents, deviations, and preparing SOPs.
• Standards Management: Knowledge of working standard preparation, reference standard management, and procurement.
• Validation: Experience in IQ, OQ, and PQ preparation and execution.
• QC Analyst Qualification: Knowledge of QC analyst qualification processes.
• Software Skills: Familiarity with LIMS (Laboratory Information Management System) and ERP software.

Preferred candidate profile

Injectable/Opthalmic Background