Duties and Responsibilities include, but are not limited to, the following : Responsible for organizing and directing the Validation / Calibration staff members that are directly involved in the periodic e straordinary validation and revalidation activities for Sterility facilitiesResponsabile for the overview of the Cleaning Validation, Process Validation and Media Fill.
Manage the activity with other department and external consultantsSupport critical process and equipment change controls and implement an effective and efficient revalidation program at all cGMP facilitiesManage the equipment and computerized system change control program to insure that all systems are maintained in a validated state.
Represents validation programs in regulatory settings, responds to observations during regulatory inspections and implements corrective measures in response to regulatory findings / observationsEnsures that the departmental budgets is projected and maintained to support annual revalidation and calibrationResponsible for maintaining solid working relationships with other support groups (Engineering, MS&T, QA, Manufacturing, etc.
to ensure projects and scheduled tasksDevelops corporate strategies for validation and cGxP compliance through master plans, policies, and proceduresEnsures projects are evaluated, planned and implemented within schedule and budget requirements Validation Manager - Azienda farmaceuticafarmaci steriliSkills Required : Requires a BS / BA in Engineering, Chemistry, Life Sciences, or related field and at least 5 years of experience in GMP environmentStrong technical writing skills to develop GMP documentsExcellent communication skillsExperience with process validation area is a mustKnowledge of GMPsExperience developing staff regarding teamwork, validation / calibration techniques and procedures to ensure GMP compliance.
Our client, a pharmaceutical company that produces sterile drugs, is looking for a Validation ManagerOttima opportunità di carriera.