Qc Chemist - FDA

Role & responsibilities

Job Profile

Reviewing New Drug Applications (NDAs): Evaluating the manufacturing methods, facilities, and controls, and proposed labels.

Summarizing findings: Recommending approval or nonapproval of the application.

Researching: Studying the effects of food, dietary supplements, drugs, antibiotics, and agricultural chemicals on livestock and humans.

Analyzing substances: Determining the composition and concentration of elements in substances.

Writing technical reports: Detailing methods and findings.

• Prepare compounds, test solutions and reagents to conduct tests and experiments, then advising and coordinating on test procedures.
• Determine the relationships of chemical and physical properties, composition, structures and reactions of organic and inorganic compounds using chromatography, spectrophotometry and spectroscopy techniques.
• Develop, improve and customize equipment, products, formulas, analytical methods and processes.
• Consult with engineers and scientists on analysis, interpretation and development of tests.
• Induce reactions to chemical substances with light, energy, heat and chemical catalysts.
• Document findings in technical papers and reports, preparing specifications and testing standards.
• Clean and maintain laboratory instruments and equipment, making sure that all the technology is working correctly, if it isnt, troubleshoot the issue or problem. Conduct quality control tests to ensure no compounds or equipment are contaminated.
• Order laboratory supplies and chemicals, keeping an eye on expiration dates
• Defining quality systems and procedures and ensuring strict compliance thereof
• Responsible for management of QC inspection of raw materials, in-process materials and finished products.
• Identifying and resolving in-house quality related issues to minimize incidences of rejections/reworking.
• Identifying requirements of various inputs for lab operations and ensuring availability there off.
• Providing training on Quality System to new recruits and other personnel in operations.
• Planning and management on Operational Expenditure and Capital Budgets.
• Necessary actions for product approval and supplier registration at RDSO
• Application of statistical techniques for improvement of process or process capability studies.
• Maintain documentation in compliance with quality systems and procedures.
• Preparation of Patent write-ups as per the requirement of Indian Patents Act, and co-ordination with Patent .
• Attorneys/Examiners for patenting of developed oils/lubricants.
• Providing technical support including conducting Training programmes on Metalworking lubrication, and
• Quality assurance of Machinery oils & Lubricants
• Development and Standardization of Testing /Analytical & In-house Calibration methods and arranging external calibrations thereof form time to time to ensure consistency, reliability and accuracy of results.
• Laboratory Management, Maintenance of chemical laboratory
• Handled sophisticated analytical instruments like Spectrophotometers (Optical Emission, Infrared/FTIR, UV, AAS), Gas & Liquid Chromatography
• Familiar with oil testing methods including transformer oil testing
• Method development and validation, Proficiency Testing / Inter-laboratory testing, Calibration activities
• Monitoring adherence to quality systems, comply with quality standards & maintaining requisite documents
• Preparing the Review and report compilations of analytical method development data and calibration reports.
• Taking appropriate quality measures including preparation / maintenance of necessary documents and conducting audits to ensure compliance with standards

Instruments to be handled

• Cold Cranking Simulator
• Total Base Number Titrator
• ICP-OES (Agilent 5110)
• Karl Fischer Titrator
• FTIR
• Pour Point
• HTHS
• Flash Points by Cleveland Open Cup Tester
• BCT (box compression test)
• ECT (Edge crush test)
• High Temperature Foaming Tester (tendency, stability)

Preferred candidate profile

Perks and benefits