Project Validation Specialist - Intellectt INC

Role: Project Validation Specialist

Location: Anasco, PR

Duration: 12 Months

Description:

Data Gathering Participate in the discovery and compilation of required documentation to be evaluated.

Gap Assessments Support assessment of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labelling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.

Remediation Plan Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system.

• Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR and Design History File (DHF) remediation program. Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments. Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR. Generate and execute validation protocols, including the coordination of all activities required for protocol completion. Interact and coordinate activities with other departments, external vendors, and customers, as required. Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others. Provide training in the updated manufacturing documentation as applicable. Analyze manufacturing process information / data, develop, where necessary, technical justification, rationale and/or other information as required by the company to mitigate risk to acceptable level with adequate documentation. Report project status and progress periodically to site management.