Company Jobs

Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA.

Ability to collaborate effectively with cross-functional teams, including R&D, marketing, sales, finance, and regulatory affairs, to achieve project objectives and deliver end to end results.

Entry of clinical data into Clinical Data Management Systems and administration of documents to produce efficient, quality data management products that meet customer needs.

Site Support Assistant is responsible for the timely delivery of delegated tasks and provides ongoing support to Global Investigator Support Department by assisting on workflow and maintaining Global Investigator Support documentation and communications to all parties.

Analytical Research and Development enabling Chemical Development and API Supply. Routine analysis of in-process and isolated samples for early intermediates and APIs using chromatographic and wet analytical techniques

Deviation and CAPA Support. Assist in documentation and tracking of deviations, change controls, and CAPAs. Participate in root cause analysis and follow-up actions.

Proven track record demonstrating top sales accomplishments. Ability to develop relationships with physicians, nurses and ancillary staff within academic hospitals, clinics and private practice facilities.

Responsible and Accountable for Preparation / Compilation of registration, re-registration dossier and variation application as per registration guidelines for various countries.

Handling of Change Controls, CAPA's, Unplanned Deviations, Planned Deviation, Investigations and Audit Management in Trackwise software

To have knowledge of ICH guidelines and other regional regulatory requirements including USFDA, EMA, NMPA, TGA, CADIFA and other global regulatory market.