QA CSV Engineer
Responsible for developing a process for and performing of validation of computer and/or automation systems compliance current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11.
· Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
· Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
· Keeps systems and processes developed for computer and automation systems validation up to date and compliant.
· Gives guidance on all activities related to computer and automation systems validation.
· Support activities include, but are not limited to, SOP creation, documentation review and approval including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
· Compiles and analyses validation data and makes recommendations for changes and/or improvements.
· May also investigate and trouble-shoot problems which occur and determine solutions.
· Maintains all documentation pertaining to computer systems validation.
· Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
· Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.
· As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies.
· Coordinates assigned projects and represents department on project teams.
· Serves as an information resource for computer systems validation to validation engineers, contractors and vendors.
· Resolves computer systems validation issues of moderate scope with limited direct supervision.
· Bachelors degree in a technical, scientific or related field is preferred.
· Min 6 years of related industry experience
· Min 3 years of experience in CSV system development life cycle is required.
· Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
· Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required.
· Strong knowledge of system development life cycle is required.
· Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.
· Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required.
· The ability to travel up to approx. 10% (domestic and international) is required.
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