Key Responsibilities
Software Knowledge: Waters 2487
- Analytical Testing: Perform routine HPLC testing to quantify active pharmaceutical ingredients (APIs), preservatives, impurities, and degradation products in injectable formulations.
Qualifications & Requirements
- Education: B.Sc / M.Sc in Chemistry or B.Pharm / M.Pharm.
- Experience: 2 to 6 years of specific Quality Control (QC) laboratory experience, preferably within a sterile or injectable manufacturing plant.
- Knowledge Requirements: Strong understanding of ICH guidelines, compendial testing (USP/EP), and method validation/verification.
Core Competencies
- Data Integrity: Strict adherence to ALCOA+ principles.
- Troubleshooting: Ability to resolve chromatographic issues (pressure drops, baseline noise, peak tailing) rapidly.
- Collaboration: Strong coordination with production, quality assurance, and packaging teams to release batches without delay.
- Method Operations: Prepare and standardize mobile phases, volumetric solutions, and reagents for accurate chromatography.
- Instrument Maintenance: Operate, calibrate, and troubleshoot HPLC systems (including Empower software) to ensure proper system suitability before analysis.
- Documentation & ALCOA+: Ensure all raw data, chromatograms, and test results are meticulously recorded and compliant with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- OOS/OOT Investigation: Identify Out-of-Specification (OOS) or Out-of-Trend (OOT) results, immediately report deviations, and assist in root-cause investigations.
- Compliance & Audits: Support internal and external regulatory audits (e.g., USFDA, MHRA) by providing thorough analytical documentation and responding to inquiries.
Pay: ₹30,000.00 - ₹40,000.00 per month
Work Location: In person
