Company Jobs

Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.

Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.

End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.

Granulation, Compression, FBE, Cyto, Sex Hormones Blister Packing - Primary, Capsule Hard Gelatine and Soft Gelatine.

Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry. Within a decade since inception in 2007, Biophore has emerged as a trusted partner in the generic industry across US, Europe and other regulated markets.

Ability to conceptualize and drive large-scale marketing strategies with an execution-first approach. Experience in leading teams, collaborating with sales, and driving prescription demand at a national level.

Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA. Review of Analytical Method Validations, Method Transfers, Protocols & Reports. Experience in review of HPLC, GC, LCMS calibration data & Analytical Data review. 

Review of various formulation and packing development, technology transfer documents like but not limited to Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol

Use technical knowledge to perform in-depth review of API drug master file as per current US FDA expectations; identify deficiencies and formulate strategies to resolve them. Close coordination with Packaging material and Excipient vendors, placing orders, arranging technical documents to Analytical and Regulatory teams.