Executive, Analytical R&D

3 - 7 years

0 Lacs

Posted:4 weeks ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

In this role, you will be primarily focused on ensuring that analytical instruments and laboratory systems are calibrated and/or qualified, maintained, and documented to GLP/regulatory expectations. Your responsibilities will include managing equipment breakdowns and lifecycle, standards, compliance documents, and supporting audits/inspections. - Calibration & Standard management: - Execute and document calibrations for analytical instruments (HPLC, GC, balances etc.). - Maintain traceability of records. - Manage calibration records, calibration labels/tags, and calibration status dashboards. - Handle the receipt, storage, issuance, and disposal of standards while maintaining their traceability. - Instrument Qualification & Lifecycle management: - Perform qualification of analytical instruments and critical lab utilities with vendors. - 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. Qualifications Required/Preferred: - 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.,

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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