Job Purpose To execute QC laboratory activities for APIs /excipients and associated materials by performing accurate and timely analysis in compliance with approved specifications, analytical methods,

GMP and data integrity requirements, while maintaining complete documentation and supporting investigations, validation, stability studies, audits, and continuous improvement of

QC operations.

Role & responsibilities

Sampling & Analysis

Perform sampling and testing of raw materials, intermediates, in-process materials, finished APIs, and stability samples.

Perform analysis using approved pharmacopoeial, validated, or approved analytical methods.

Handle instruments such as HPLC, GC, UV-Visible, FTIR, Karl Fischer, pH meter, moisture analyzer, etc., as applicable.

Documentation & Data Integrity

Record analytical results accurately and contemporaneously in worksheets, logbooks, , and other approved systems.

Ensure compliance with ALCOA+ data integrity principles.

Maintain complete analytical records, calculations, chromatograms, spectra, and raw data.

Instrument & Laboratory Control

Ensure proper operation, calibration, qualification, and preventive maintenance of laboratory instruments.

Perform system suitability and instrument checks before analysis.

Report instrument malfunction or abnormal observations promptly.

GMP & Regulatory Compliance

Follow applicable GMP, pharmacopoeial, regulatory, and site requirements.

Ensure compliance with approved SOPs, specifications, analytical methods, and safety procedures.

Support internal, customer, and regulatory audits.

OOS/OOT & Investigation





Participate in OOS, OOT, deviation, laboratory incident, and analytical failure investigations.

Provide technical inputs for root-cause analysis and CAPA.

Ensure investigation records are complete and scientifically justified.

Method Validation / Verification

Support analytical method validation, verification, transfer, and robustness studies.

Assist in preparation and review of protocols, reports, and analytical method documents.

Stability & Reference Standards

Perform testing of stability samples as per approved stability protocols.

Maintain reference standards, working standards, reagents, solutions, and their respective records.

Coordination

Coordinate with Production, QA, R&D;, Warehouse, and Engineering for timely sampling, testing, and resolution of quality-related issues.

Ensure analytical results are communicated within defined timelines.

Continuous Improvement

Identify opportunities for improvement in laboratory processes, analytical methods, documentation, and compliance.

Support implementation of CAPA, change controls, risk assessments, and laboratory improvements

Preferred candidate profile

- Minimum qualification: M.Sc. in Chemistry from a recognized university.
- Must have knowledge of sophisticated instruments like HPLC, GC, UV, IR etc
- Solid understanding and working knowledge of Quality Management Systems (QMS) and documentation practices.
- Candidate must have practical experience in handling and facing regulatory audits, including ISO 9001, WHO-GMP, and other applicable regulatory inspections.

📌 Quality Control Executive (Dahej)
🏢 Rossari Biotech
📍 Dahej