Job Description

Job Overview

To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards.

Roles and Responsibilities:

Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings). Coordinate with QA, RA, Production, and R&D for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits.

Experience

1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry

Competencies

Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. * Team player with problem-solving and analytical skills.