SENIOR QC CHEMIST & HPLC OPERATOR

Job Title: HPLC Operator / Senior QC Analyst

Location: Cherlapally, Hyderabad
Employment Type: Full-time
Department: Quality Control / Analytical
Industry: Formulation

About the Role

We are seeking a highly skilled and dedicated HPLC Operator / QC Analyst to join our Quality Control team. The ideal candidate will be responsible for performing instrumental analysis using HPLC and other analytical techniques, ensuring that all activities are carried out in compliance with GMP, GLP, and data integrity standards.

This position plays a vital role in supporting product quality, regulatory compliance, and analytical excellence within the organization.

Key Responsibilities Analytical Testing & HPLC Operations

• Perform HPLC analysis for finished products, in-process samples, and stability batches as per approved methods.
• Responsible for entire HPLC operation and maintenance, including system suitability, column care, and data review.
• Conduct assay, related substances, dissolution, and impurity profiling for solid and liquid formulations.
• Execute analytical method validation, transfer, and verification according to ICH Q2 (R1) guidelines.
• Perform troubleshooting and preventive maintenance of HPLC and other analytical instruments (GC, UV, FTIR, etc.).

Sample Handling & Preparation

• Prepare standard and sample solutions accurately as per SOPs and analytical procedures.
• Label, document, and store samples according to GMP and data integrity requirements.

Documentation & Compliance

• Record and maintain analytical raw data, chromatograms, and results in compliance with Good Documentation Practices (GDP).
• Ensure strict adherence to GMP, GLP, and ALCOA principles in all quality operations.
• Review analytical results and prepare COAs, analytical reports, and trend summaries.
• Participate in OOS/OOT investigations, deviations, and CAPA implementation with QA and QA-QC leads.

Audit & Quality Support

• Support internal, customer, and regulatory audits (USFDA, MHRA, WHO, TGA, etc.) by providing analytical documentation and justifications.
• Assist in stability studies and periodic review of analytical data.
• Coordinate with cross-functional departments such as Production, QA, and R&D for analytical testing and method transfer.

Qualifications & Experience

• B.Sc. / M.Sc. in Chemistry, Pharmaceutical Chemistry, or related discipline.
• 4-9 years of hands-on experience in HPLC operations within a pharmaceutical formulation unit.
• Proficiency in HPLC software such as Empower, Chromeleon, or OpenLab.
• Strong understanding of GMP, GLP, ICH, and regulatory requirements related to formulation testing.
• Ability to perform precise analysis and maintain data integrity.

Preferred Skills

• Experience with stability testing, impurity profiling, and method validation for oral or sterile dosage forms.
• Knowledge of instrument calibration, equipment qualification (IQ/OQ/PQ), and electronic data management systems.
• Exposure to regulatory audits and compliance documentation.

Job Type: Full-time

Pay: ₹300,000.00 - ₹800,000.00 per year

Work Location: In person