BSc/MSc Analytical & Organic Chem Jobs at Pelltech Healthcare, Apply on Rasayanika
Analytical Method Validation
Company – Pelltech Healthcare
Budget – Up to 5 LPA
Interview mode – Virtual
Location – Maharashtra
Experience – 3-5 years
To conduct and document analytical method validation (AMV), method verification, and method transfer activities for raw materials, in-process samples, and finished pharmaceutical products in compliance with ICH Q2(R1), GMP, and regulatory standards.
Key Responsibilities
1. Analytical Method Validation
□ Perform validation of analytical methods as per ICH Q2(R1) guidelines for:
□ Assay and related substances (HPLC, UV)
□ Dissolution, content uniformity, residual solvents (GC)
□ Identification and other physicochemical parameters
□ Conduct validation parameters: specificity, accuracy, precision, linearity, robustness, LOD/LOQ, system suitability, etc.
□ Document results in validation protocols and summary reports.
2. Method Verification
□ Verify compendial methods (IP/BP/USP/Ph.Eur.) for RM/FP/IP samples.
□ Confirm suitability of method for intended use before routine application.
□ Prepare method verification reports and submit for review/approval.
3. Method Transfer
□ Participate in analytical method transfer (AMT) from R&D or third-party units.
□ Execute comparative testing for transferred methods and compile transfer protocols.
□ Coordinate with sending/receiving sites for method harmonization and troubleshooting.
4. Instrument Handling
Operate and troubleshoot instruments such as:
□ HPLC (Empower, LabSolutions, Chromeleon)
□ GC (Headspace, FID)
□ UV-Visible Spectrophotometer
□ FTIR, Dissolution Apparatus, TOC (if applicable)
5. Documentation & Compliance
Prepare and review:
□ Validation protocols and reports
□ Analytical worksheets and system suitability documents
□ Adhere to GMP, GLP, and ALCOA+ principles.
6. Audit Readiness & Regulatory Support
□ Ensure all AMV data is audit-ready and compliant with regulatory expectations.
□ Support in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.).
□ Address audit observations related to analytical validation.
Instruments & Software Used
□ HPLC, GC (Headspace, FID)
□ UV-Vis Spectrophotometer, FTIR
□ Dissolution Testers
□ CDS Software: Empower / LabSolutions / Chromeleon
Qualification
B.Sc. (Analytical / Organic Chemistry)
M.Sc. (Analytical / Organic Chemistry)
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