Pharma CLIM Services S.A de C.V jobs and careers

About Pharma CLIM Services S.A de C.V

Regulatory and Compliance Regulatory and Technical Support for Medicinal and Medical device development and new product launch (local or foreign) because of granted authorizations to manufacture (GMP) and commercialize the new product (MA). Support for renewal and post approval changes of establishment´s and/or product´s authorizations. Support for Queries management and remediation efforts. Management of procedures before COFEPRIS. Regulatory and Technical Support to obtain establishment authorizations from: COFEPRIS, FDA, INVIMA, ANVISA, etc. Quality Compliance Support for proper Change Control and CAPA management, Readiness Inspection, Annual Product Review, SOP and Master documents writing or review for further upgrading, as well as SMF management. Engineering (layouts and flows) Support to design/refurbish a pharmaceutical establishment, commissioning, Tech-transfer, as well as manufacturing, quality, and supply chain engineering. Validation Technical and regulatory support to pursue proper Areas, Critical Systems, Equipment, Manufacturing process, Analytical Method, Cleaning and CSV qualification/validation, as well as CPV and maintenance of validates/qualified state. Lean Manufacturing and Six Sigma Support to achieve Process improvement by flow and process mapping/VSM and other tools to led in cost reductions, cycle time reduction, scrap reduction, optimization of inventory management, productivity improvement, etc. Project Management New assets implementation, changes in product portfolio, New product Launch, post-approval changes, regulatory conformity, etc. Personnel Evolution Support for personnel recruitment, GXP training and tailored made training. Other Management of controlled substances. Vendor’s selection, approval, and management. Translation Service (EN-SP).