Job Detail

Job Description

Ø  Proficient in operating HPLC

Ø  Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).

Ø  Analyse API, Raw Materials and Finished products for Assay, Impurities & Dissolution study using HPLC instrument with minimum supervision.

Ø  Review technical data, documents, and proposals as required.

Ø  Troubleshoot technical issues/ difficulties with methods.

Ø  Coordinate with team members to perform method transfers between R&D group to QC group.

Ø  Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures.

Ø  Strong interpretation of routine analysis or tests.

Ø  Be able to write lab reports.

Ø  Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods.

Ø  Be able to work under GMP guidelines and be proficient with USP and pharmaceutical testing.

Ø  Competent research and study skills to learn about innovative methodologies and equipment used for problem-solving and troubleshooting.

Ø  Design, preparation, and production of study materials including procedure manuals.

Ø  Responsible for the testing of raw materials, finished products and stability samples by instrumental and wet chemistry methods and described in compendia references or in-house methods.

Ø  Perform other duties as assigned by the Laboratory manager.

Ø  Sample preparation and Mobile phases preparation.

Ø  Documentation: Ensuring accurate reporting in lab books.

Ø  Using a wide range of sophisticated equipment and instruments to conduct analysis and research and troubleshoot instrumentation/methods.

Ø  Perform other departmental tasks such as cleaning, supply ordering, assist with instrumentation training and maintenance, etc.

Ø  Perform analytical tests utilizing HPLC and other laboratory instruments.

Ø  Mentoring/training junior staff members and Imparting training to new recruits for operation, calibration and preventive maintenance of HPLC.

Ø  Writing SOPs.

Ø  Ensure that work is performed in compliance with good manufacturing practices (GMP), standard operating procedures (SOPs) and the current test method.

Ø  Participates in general lab duties, including clean-up, administration, logbook review and operations support

Ø  A solid background and understanding of Chemistry is mandatory

Skills Required

• HPLC
• SOPs
• analytical tests
• USP
• pharmaceutical testing
• GMP/GLP
• Standard Operating Procedures
• Analyse API
• R & D
• QC
• USP
• EP pharmacopeia
• Testing instruments