QA / QC Chemist (QMS)

FMC India; Vadodara; On-site; INR 600,000 - 900,000; Full time

Job summary

FMC India is seeking a detail-oriented analytical lab professional responsible for testing raw materials, packaging materials, intermediates, and finished products. The candidate will ensure data integrity, prepare COAs, and perform stability studies in a GMP/GLP environment.

The role requires proficiency with HPLC, UV, and other analytical instruments, along with SAP experience and knowledge of ISO 9001/ISO 14001. Calibration, audits, and documentation are essential parts of the job.

Qualifications

• Adhere strictly to safety and compliance requirements in GMP/GLP environments.
• Perform testing and reporting of raw materials, packaging materials, intermediates, and finished products to meet quality standards.
• Record and interpret data accurately, maintaining detailed documentation of all tests and prepare Certificates of Analysis (COA).
• Conduct stability studies to assess shelf-life and storage conditions.
• Calibrate and maintain laboratory equipment to ensure accuracy and reliability of results.
• Participate in internal audits and inspections, providing data as required.

Responsibilities

• Test using instruments such as HPLC, UV, particle size analyzer, and pH meter.
• Prepare and maintain documentation for COA and QA records.
• Ensure compliance with ISO 9001 and ISO 14001 requirements.
• Support regulatory audits and inspections with accurate data.
• Maintain lab equipment and calibration schedules.

Skills

HPLC

SAP

GLP

Statistical analysis

ISO 9001/ISO 14001 knowledge

Tools

HPLC

UV spectrophotometer

Particle size analyzer

pH meter

Job description

• Adhere strictly to regulatory requirements and company policies regarding safety and compliance requirements.
• Perform testing and timely reporting of raw materials, Packaging material intermediates, and finished products using various chemical and instrumental methods to ensure quality standards are met.
• Conduct tests using instruments such as HPLC, UV, Particle size analyzer, pH meter and other analytical equipment.
• Record and interpret data accurately, maintaining detailed documentation of all tests performed. Prepare Certificates of Analysis (COA)
• Conduct stability studies to assess product shelf-life and storage conditions.
• Calibrate and maintain laboratory equipment to ensure accuracy and reliability of test results.
• Participate in internal audits and inspections, providing necessary support and data as required.
• Knowledge of SAP.
• Maintaining documentation as per ISO 9001 and ISO14001.
• Knowledge of 6S and Good Laboratory practices
• Familiarity with regulatory standards such as ISO 9001, ISO 14000 and Laboratory practices.
• Proficiency in analytical techniques, including chromatography methods like HPLC
• Knowledge of statistical analysis software and quality management systems