QC Chemist

2 - 5 years

0 Lacs

India

Posted:1 day ago| Platform:

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Skills Required

qc stability analysis spectrophotometer coordination service documentation reports test data analyze packaging calibration audit support integrity communication lims audits compliance

Work Mode

On-site

Job Type

Full Time

Job Description

Job description :- Instrumental Analysis: Perform routine and stability analysis of raw materials, intermediates, and finished products using HPLC, UV-Vis Spectrophotometer, FTIR , etc. Operate and calibrate analytical instruments as per SOPs and regulatory guidelines. Troubleshoot HPLC and other lab equipment in coordination with service engineers when required. Documentation & Compliance: Prepare and maintain analytical reports, test data sheets, protocols, and logs as per GDP (Good Documentation Practices). Ensure all QC activities comply with cGMP, GLP, and other regulatory guidelines . Assist in investigation and documentation of OOS, OOT, and deviations . Sample Handling & Testing: Receive and analyze raw material, packaging material, in-process samples, and finished goods as per approved specifications. Maintain proper sample disposal records. SOP & Record Management: Review and update Standard Operating Procedures (SOPs), specifications, and analytical methods. Maintain laboratory notebooks, logbooks, equipment usage logs, and calibration records accurately. Equipment Handling & Calibration: Operate and maintain lab instruments including HPLC, Dissolution Test Apparatus, pH meter, Analytical Balance, etc. Conduct periodic calibration and qualification of instruments. Audit Readiness: Prepare and support internal and external audits (e.g., USFDA, WHO, MHRA). Maintain complete and audit-ready documentation at all times. Key Skills & Competencies: Hands-on experience in HPLC analysis and troubleshooting . Strong understanding of analytical chemistry, GMP, GLP , and ICH guidelines . Attention to detail, data integrity, and documentation accuracy. Good communication and team coordination skills. Proficiency in MS Office and LIMS (preferred). Qualifications: B.Pharm / M.Pharm / M.Sc / B.Sc (Chemistry or related field) Minimum 2–5 years of experience in QC in a regulated pharmaceutical environment . Additional Requirements: Willingness to work in shifts (if applicable). Sound knowledge of safety protocols and laboratory hygiene . Good analytical and problem-solving abilities. Familiarity with regulatory audits and compliance standards . Job Types: Full-time, Permanent Pay: ₹18,000.00 - ₹25,000.00 per month Benefits: Cell phone reimbursement Health insurance Paid sick time Provident Fund Schedule: Day shift Supplemental Pay: Joining bonus Performance bonus Yearly bonus Work Location: In person Expected Start Date: 01/07/2025

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