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.
Qualifications
M.Sc.
About Us
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.
About The Team
The
Human Resources team
partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.