+3 years' experience in a pharma regulated warehouse environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
Organizational and management skills to coordinate multi-discipline project groups
Ability to speak, present data, and defend approaches in front of audiences and inspectors.
Ability to comprehend technical information related to equipment, processes, and regulatory expectations
Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
Responsibilities
Provide quality oversight for validation activities related to products and facilities, utilities, equipment (FUE).
Support the development of validation plans for specific system implementation projects.
Supporting and reviewing/approving, solutions.
Support validation policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured, validation techniques/approaches and systems utilized on site.
Lead and represent QA Validation in multi-departmental meetings & project teams.
Identifies and implements improvements to the QA Validation systems.
Participation in the change control program for modifications to qualified systems.
Quality oversight for the Revalidation Evaluation program.
Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required.
Education
Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
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