5+

Responsible for Safety Data Exchange Agreement SDEA management. Responsible for preparation and maintenance of Pharmacovigilance System Master File PSMF

Walk In - Manufacturing, Engineering & Quality Functions - Injectable Facility at Vadodara

Experience in IPQA, Process & Cleaning Validation, Media fill Air- flow study, Continuous process verification, Batch release, Finish product sampling,Shop floor activities

To perform investigation for Deviation, OOS, OOT observed at plant.Preferably to have regulated market Science based scale up factor based Tech transfer experience.

Collaboration with R&D and other stakeholders to enable timely filing and review of documents for EU, UK, CA, AUS for solid oral and topical dosage forms RA strategy in collaboration with partners with focus on cost implications.

Experienced in qualification documents preparation i.e. protocol preparation. Risk assessment, technical documents review and execution. Hands on experience on QMS - investigation, change control, impact assessment: Drafting and review.

Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia. Prepare responses to deficiency letters received from various agencies.

Looking for suitable candidates for its Formulation facility at Dahej, Bharuch, Gujarat. Experience of FG Testing and Stability, HPLC, Dissolution, Gas chromatography, AMV and GLP section.

Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control