Job Description

Requirements:

This is a GLP-focused role. The primary responsibility is to ensure analytical instruments and laboratory systems are calibrated and /or qualified, maintained, and documented to GLP / regulatory expectations. The person will manage the equipment breakdowns and lifecycle, standards, compliance documents, and support audits/inspections.

Core responsibilities

Calibration & Standard management

To execute and document calibrations for analytical instruments (HPLC, GC, balances etc.). To maintain traceability of records. Maintain calibration records, calibration labels/tags and calibration status dashboards. Manage receipt, storage, issuance, and disposal of standards. To maintain traceability of standards.

Instrument Qualification & Lifecycle management

Execute qualification of analytical instruments and critical lab utilities with vendor. Oversee preventive maintenance and breakdowns of instruments. Maintain all Instrument records.

GLP Documentation & Compliance

Prepare and maintain GLP-compliant documents, calibration SOPs, qualification documents, equipment lifecycle procedures and instrument-specific work instructions. Ensure all records meet GLP requirements for traceability, metadata, and raw data retention.

Required / Preferred skills & attributes

Deep working knowledge of GLP principles and documentary expectations. Practical experience in calibration and qualification of analytical instruments. Reasonable documentation skills (writing SOPs, protocols etc). Working knowledge of data integrity principles and electronic records (21 CFR Part 11 awareness desirable).
Good communication skills and ability to interact with QA, engineers, vendors and labs.



M.Sc.



Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.