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Analytical Chemist

* Perform routine and non-routine analysis of raw materials, intermediates, and finished products using analytical techniques such as HPLC, HPLC-MS, Particle size analyser, GC, UV-Vis spectroscopy, and titrations.

* To ensure timely and adequate support with respect to availability of all lab reagents, reference standards etc.

* Manage the loading, pooling, and testing of stability samples for product development and licensed product stability.

* Perform analytical development testing and technical transfer analysis when required.

* Perform any investigational sample analysis to support complaint, out of specification, and out of trend investigations.

* Assist in the investigation of laboratory deviations and out-of-specification results.

* Escalate major and critical compliance issues through the site PQS process.

* Prepare and standardize chemical reagents and solutions for laboratory use.

* Calibrate and maintain laboratory equipment in accordance with SOPs and regulatory requirements.

* Generate, process, and report raw data from analyses in accordance with data integrity policies and regulatory requirements.

* Document test results accurately and maintain detailed records of all laboratory activities.

* Follow all safety protocols and maintain a clean and organized work environment.

* Collaborate with cross-functional teams to troubleshoot technical issues and improve laboratory processes.

* Stay current with industry trends and regulatory requirements related to QC chemistry e.g. EUGMP Chapter 6 guideline

* To update existing procedure and implement new procedures as an when necessary

* To Support the Process Validation and cleaning validation testing activities

* Support internal audits, customer audits & regulatory inspections and implement necessary CAPA.

SECONDARY RESPONSIBILITIES

* Reporting potential risks identified in the QC Laboratory.

* Alert other team members of issues that may be detrimental to quality or pose a risk to individuals.

* Take responsibility for own development, learning and performance and demonstrating skills and activities to others who are undertaking similar work.

* Contribute to the effectiveness of the team by reflecting on own and team activities and making suggestions on ways to improve and enhance the team’s performance.

* To undertake such duties as may be required from time to time as are consistent with the responsibilities of the grade and the needs of the service