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
Having Knowledge of Analytical Method Validation, Verification and Method Transfer. Having skill for data Interpretation, troubleshooting. Pharma knowledge of Solid orals and Quality process.
Accuprec Research Labs Pvt Ltd. is FDCA approved, OECD-GLP, NABL accredited and ISO 9001:2015 certified CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA. Accuprec provides all type of Pharmaceutical testing solutions to its domestic and MNC clients.
Experience in pharmaceutical research, experimentation, and data interpretation based on analytical results. Proficiency in laboratory techniques, equipment handling, and GMP knowledge.
Vendor Management, Contract testing laboratories qualification, Qualification and management of contract vendors and external service providers, QMS and compliance.