Looking for QC Chemical Officer/Executive for Pharma company based at Ankleshwar
Looking for QC Chemical Officer/Executive for Pharma company based at Ankleshwar
Posted on :
07-09-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
The job description is as below:
To perform High Performance Liquid Chromatography analysis for various pharmaceutical tests including Related Substances in compliance with21 CFR Part 11and cGMP guidelines. The role includes calibration troubleshooting integration and data review activities related to HPLC.
Key Responsibilities:
- Perform routine and non-routineHPLC analysisforAssayRelated SubstancesContent Uniformity and other quality control tests.
- Strong analytical method validation knowledge and performance.
- Prepare sample sets analytical methods and sequence tables for HPLC runs.
- Ensure all HPLC analyses comply with21 CFR Part 11 includingaudit trail reviewand electronic data integrity.
- Review and approve HPLC integrationand raw data per method-specific parameters.
- ConductHPLC calibration and performance verificationas per standard procedures.
- Identify and troubleshootHPLC-related issuesincluding baseline noise pressure issues leakages and pump errors.
- Maintain complete and accurate records of all QC activities in accordance with cGMPanddata integrityprinciples.
- Participate indeviation investigationsOOS andchange controlsas required.
- Support duringregulatory auditsand internal inspections by providing required documentation and clarification.
- Coordinate with QA Production departments for sample and method transfers.
- Maintain proper documentation ofinstrument logscalibration records andanalytical reports.
- Ensure timely completion of assigned tasks to meet release timelines.
Qualifications & Experience:
- / / . in Chemistry or related field.
- Minimum1 -2 years of hands-on experience with HPLC analysisin a pharmaceutical QC environment.
- Sound knowledge ofHPLC troubleshootingmethod development andinstrument maintenance.
- Working knowledge ofEmpower / LabSolutionsor other chromatography data systems (CDS).
- Familiarity with21 CFR Part 11 complianceGMP andaudit trail reviewpractices.
Skills Required:
- Strong analytical and problem-solving skills.
- Attention to detail and data integrity.
- Good understanding of chromatographic principles.
- Team player with good communication skills.
- Ability to work in a fast-paced regulated environment.
Preferred:
- Knowledge of other analytical techniques like UV IR
For further discussion please call Megha on or you can share your resume on
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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