Senior Technician - Pharmaceuticals

Chemistry

Chemistry/ Maths and Physics

• Responsible for analytical method development for Related Substances, Assay, Dissolution
Dissolution profile in different media, and Residue analysis for drug products (Tablets/
Capsules) by HPLC / UPLC / UV- Visible spectrophotometer.
• Preparation and review of Development reports, Validation protocols, Validation reports
and conducting validations for products intended for Generic market.
• Reviewing STP’s, Specifications and Sop’s for analytical department related products and
instruments. Preparation and review of the stability compilation data during product development.
• Actively participating in product development strategies ensuring the timely completion of
projects.
• Literature survey for project, guidelines and updating the current developments in
analytical field.
• Responsible to Global Analytical method transfer, coordinating with Quality control team to resolve the technical related issues
• Trouble shooting of Analytical Instruments and Methods.
• Effectively involved in the analytical queries from regulatory authorities
• Training the analyst to complete the analyst qualification and on job training in various
analytical techniques.
• Addressing the internal audit conducted by the QA Department.
• Ensure to perform preventive maintenance and calibration of analytical instruments as per
Schedule
• Indenting Chemicals, Columns, Reference standards and Impurity standards and follow up.
• Ensuring Lab safety.

• Preparation and review of Development reports, Validation protocols, Validation reports
and conducting development and validations for products intended for Generic market.
• Actively participating in product development strategies ensuring the timely completion of
projects.
• Exploring latest analytical developments in the pharmaceutical industry.
• Trouble shooting of Analytical Instruments and Methods.
• Effectively involved in the analytical queries from regulatory authorities.
• Responsible to Global Analytical method transfer.
• Responsible for developing methods for estimation of ions and polar compounds by ion
chromatography.
• Ensuring the Lab safety

• HPLC method development & method validation for drug products. Conducting the stability studies.
• Pharmaceutical products including stability studies.
• Identification of unknown impurities by using analytical techniques.
• Preparation and review of development reports, validation protocols, summary reports and test procedures.
• Active participant in analytical method transfer and analytical complaints.

• HPLC method validation for active pharmaceutical ingredients.
• Preparation of COA’s for raw material and finished product.
• In-process and finished product analysis.
• Preparation and certification of in-house working standards.
• Calibration of Instruments like HPLC, UV-Visible Spectrophotometer, Dissolution tester
• Performing the comparative dissolution profiles of generic drug product Vs. Innovator product with dissolution profiles in different media (DPDM).

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