· Provide project management oversight for validation activities related to Company's products, process and cleaning validation activities.
· Developing validation plans and rationale for process and cleaning validation studies.
· Execute validation activities related to process and cleaning.
· Lead and represent Validation in multi-departmental meetings & project teams.
· Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
· Participation in the change control program for modifications to qualified processes.
· Establish Site 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 by Company, validation techniques/approaches and systems utilized at Company
· 5+ years' experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process and cleaning validation.
· Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
· Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process and cleaning validation expectations.
· Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
· Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists