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Job Description

We are looking for a proactive Quality Control (QC) Technician with strong hands-on experience in HPLC analysis, analytical testing, and laboratory operations. If you can operate in a multi-shift environment, maintain 24 7 audit readiness, and have experience in LIR/OOS/OOT investigations, instrument calibration, and GMP/GLP compliance, this chance in a pharmaceutical setup is ideal for you.

Key Responsibilities:

- Perform analysis of raw materials, intermediates, finished products, stability samples, and cleaning samples using HPLC as per approved monographs, test methods, and SOPs, ensuring accurate and timely result reporting in analytical records, LIMS, and QA documentation in line with data integrity requirements.

- Carry out routine operation, calibration, system suitability checks, and maintenance of HPLC systems, including troubleshooting of chromatographic issues to ensure consistent performance and compliance.

- Prepare mobile phases, standard solutions, and test samples; ensure proper sampling, labeling (approved/rejected), and handling of samples with full traceability and documentation.

- Maintain laboratory equipment, working areas, and controlled environments (sample rooms, chambers, etc.) in compliance with cGMP, GLP, and safety standards.

- Support preparation, review, and revision of SOPs, STPs, analytical methods,



and other QC documentation in coordination with cross-functional teams.

- Monitor and maintain inventory of chemicals, reagents, columns, and reference standards with proper stock reconciliation.

- Initiate, investigate, and document LIR, OOS, OOT, and atypical/borderline results; assist in root cause analysis and implementation of CAPA.

- Maintain data integrity through proper electronic records management, secure data entry, and adherence to 21 CFR Part 11 requirements; ensure continuous 24 7 audit readiness by adhering to regulatory requirements.

- Support instrument qualification activities including IQ/OQ/PQ protocols and assist in analytical method validation studies and method transfer activities.

- Work in rotational shifts as required, complete all assigned training programs, ensure full compliance with CAPA-related actions, and maintain high standards of housekeeping and safety within the laboratory.Qualifications

The ideal candidate will have:

- Education: B.Sc. / M.Sc. in Chemistry or B.Pharma .

- Experience: Minimum 3 to 4 years of industrial experience.

Skills Required: Ion-Chromatography.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Apply on Kit Job: kitjob.in/job/4rqgfn

📌 Quality Control Technician (HPLC) (Gujarat)
🏢 Teva Active Pharmaceutical Ingredient
📍 Gujarat