Quality Control Analyst
Piramal Pharma Solutions
Summary
The Chemistry Analyst II performs routine analytical testing using Liquid Chromatography (LC) and Gas Chromatography (GC) techniques in support of product release, stability and studies. This role requires strong technical competency in chromatographic analysis, sample preparation, instrument operation, data processing, and troubleshooting within a GMP/GLP laboratory environment.
Job description
Key Responsibilities
- Perform qualitative and quantitative analysis using GC, HPLC, UPLC, and related chromatographic systems in accordance with approved test methods and SOPs.
- Prepare samples, standards, diluents, and mobile phases following established laboratory procedures and good documentation practices.
- Execute instrument setup, calibration, system suitability checks, and routine maintenance to ensure reliable performance.
- Process, integrate, and interpret chromatographic data using software such as Empower or equivalent.
- Review chromatograms for peak integrity, retention time consistency, baseline quality, and compliance with system suitability criteria.
- Document all analytical activities in laboratory notebooks, LIMS, and controlled forms in accordance with GDP and regulatory expectations.
- Conduct investigations into atypical results, instrument issues, or method deviations, including root-cause analysis and corrective actions.
- Support method transfers, verifications, and validations by executing protocols and generating high-quality analytical data.
- Maintain laboratory readiness by ensuring proper reagent labeling, instrument logbook completion, and adherence to safety and compliance requirements.
- Collaborate with cross-functional teams (QA, Manufacturing, R&D) to support testing priorities and resolve technical issues.
Requirements
- Strong technical competency in chromatographic analysis (LC, GC, HPLC, UPLC)
- Sample preparation
- Instrument operation
- Data processing
- Troubleshooting within a GMP/GLP laboratory environment
- Adherence to approved test methods and SOPs
- Good documentation practices (GDP)
- Regulatory and safety compliance
Company overview
Piramal Pharma Solutions (PPS) is a leading global Contract Development and Manufacturing Organization (CDMO) offering comprehensive end-to-end solutions across the entire drug lifecycle. As part of Piramal Pharma Limited, the company operates through a globally integrated network of 15 facilities across North America, Europe, and Asia, serving over 500 customers worldwide. PPS provides a complete range of services including drug discovery solutions, process and pharmaceutical development, clinical trial supplies, and commercial manufacturing of APIs and finished dosage forms. The company specializes in advanced technologies such as antibody-drug conjugates (ADCs), highly potent APIs, sterile fill/finish, peptide products, and potent solid oral drug products. With a team of over 4,700 professionals and a strong track record of regulatory compliance, Piramal Pharma Solutions has established itself as a trusted partner for both innovator and generic pharmaceutical companies, delivering patient-centric solutions with a focus on quality, operational excellence, and innovation.