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Purpose - The candidate shall have the role of a reviewer in Analytical validation lab to support HPLC and mass spectrometric sequence review, audit trail review, Raw data review, AMV protocol preparation and review, Analytical Method Validation report review.

Position / Job Title - Executive/Sr Executive

Department - Analytical Department - Reviewer team

Reporting To - Manager

Location - Thane

Years of Experience - 7-10 yrs

Dosage Form - Solid Oral / Liquid Oral/ Injectables /Nasal Spray

Job Responsibilities / Deliverables

- To Support in AMV activities related to review of Analytical Method Validation/Verification/Transfer protocols and reports for compliance with specifications.
- To prepare protocols for method validation / method verification activity of Extractable Leachable, Nitrosamine analysis, Assay, RS, Residual Solvent, Particle size , etc
- To review all analytical data and reports and ensure compliance with cGMP, ICH guidelines, and SOPs.
- To verify the technical accuracy of validation studies (HPLC, GC, EL study by MS etc.), review raw data for integrity (ALCOA++), and oversee documentation to ensure methods are robust and reliable.
- To Perform technical and electronic data review of Instruments software, Chromatography data (e.g., Chromeleon, LabSolutions, SCIEX OS,



MassHunter), also Test data sheets (TDS) and Laboratory Notebooks (LNBs) to ensure data integrity.
- To Review instrument qualification records, calibration records, and system suitability test (SST) data to confirm equipment functionality.
- To Maintain accurate, complete, and reliable records, ensuring audit trails are enabled and reviewed.
- To review Standard Operating Procedures (SOPs), specifications, and technical summary reports.
- To Ensure data integrity and compliance with regulatory standards.
- Support and ensure compliance with CSV activities for laboratory instruments.
- To liaise with DQA for protocol and report approvals.
- Timely updation of SOPs as when required.
- Handle change process and QMS activities as required.

Qualifications & pre-requisites

- M. Pharm/M. Sc
- Robust attention to detail, knowledge of data integrity principles (ALCOA++), and proficiency with electronic data systems.
- Exposure to Solid / Liquid Oral dosage forms.
- Candidate should be good in technical / scientific writing.
- Well versed with HPLC and Mass spectrometers technicals.

Additional notes

- Candidate is expected to work in all shifts.

📌 Executive (India)
🏢 Rubicon Research
📍 India