Company Jobs

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.

Bachelors degree in life sciences or business. Experience in consulting management in the life sciences, pharmaceutical/ biotech consulting industry or equivalent industry role

Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents. Writers and edits clinical regulatory documents, including submission summaries and other complex documents.

Ensures that direct reports have development and training plans, according to IDP process. Coaches the direct reports on a regular basis, and plans, organizes coaching with external providers if needed.