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QA Validation Associate

Manufacturing / Production
Siobhán Lane
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Job Reference: JO-1910-64793_1583419463



· 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.

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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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