VALIDATION MANAGER at D.O.C. S.r.l. - Documentation Organization and Consultancy - Settala, Lombardia, Italy
Validation Specialist - Specialista di convalida Farmaceutica (CSV)
Established in 1997 DOC is an Italian consulting company with international experience in the cGMP Compliance & Validation for the pharmaceutical industryThanks to a constant business increase generation and in order to satisfy the market demand, in 2014 the company opened a brand-new headquarters able to host training sessions and seminars.DOC core business is mainly addressed to pharmaceutical companies and their suppliers such as Engineering & Contracting Companies and Original Equipment Machine (OEM) manufacturers. In this working environment, DOC plays for its Clients the role of "System Integrator", acting as "Communication Platform & Facilitator" between the cGMP Compliance Requirements (the complying of which is the ultimate Target of any Pharmaceutical System) and the Final Users. The result is a totally validated and functional system.Initially focused on the qualification of pharmaceutical facilities including manufacturing equipment and critical utilities systems, along the years DOC expanded and specialized its service portfolio, currently embracing the full cGMP compliance of pharmaceutical manufacturing processes for any kind of finished drug form like APIs, solid and liquid. Specifically DOC operations are organized in the following service segments: • Equipment and System Qualification & Validation • Instrumentation Calibration & Maintenance• Product & Process Validation• cGMP Consultancy and TrainingDOC service portfolio is inspired and developed considering the GMP V-model Validation Life Cycle starting from the User Requirement Definition of a new system to the routine Qualification Maintenance of an existing one. Beside, all the activities and services are conducted according to the "Validation Life Cycle Approach" in order to guarantee the full traceability and documented evidence.For further information, please visit our website: www.docvalidation.it