Quality Assurance Validation Specialist

Requirements:

• 7-10 years of QA Validation, Validation Engineering, or CQV experience within pharmaceutical/biotech manufacturing.
• Strong knowledge of GMP validation, change controls, protocol review, and qualification activities.
• Experience supporting capital projects and/or facility utility qualification (WFI, HVAC, clean utilities).

Job Description:

Our client is seeking a Quality Assurance Validation (QAV) Specialist to serve as the primary Quality Assurance representative supporting multiple capital projects within a pharmaceutical manufacturing environment. This individual will provide quality oversight throughout the validation and qualification lifecycle for projects involving manufacturing suites, utilities, and facility infrastructure systems. The QAV Specialist will partner closely with Capital Project Managers while operating within the site's Quality Assurance Validation organization. The role is responsible for reviewing and approving validation documentation, change controls, protocols, deviations, and final reports while ensuring compliance with GMP regulations, internal quality standards, and project timelines.

Key Responsibilities :

• Serve as the primary QAV representative for assigned capital projects, including: Suite AB Environmental (ENV) projects Water for Injection (WFI) systems HFS29 and other site capital initiatives.
• Review and approve change controls and associated impact assessments.
• Review and approve action items, conditions for release, and summary actions.
• Ensure all quality requirements are appropriately assessed and documented.
• Review and approve qualification and validation protocols prior to execution.
• Provide QA oversight during execution activities.
• Review and approve deviations generated during qualification activities.
• Review executed protocols, supporting data packages, and validation deliverables.
• Review and approve qualification and validation summary reports.
• Participate in weekly and ad hoc project meetings.
• Collaborate with project managers, engineers, validation personnel, and quality stakeholders.
• Provide quality guidance while escalating non-standard validation approaches to Pfizer QAV leadership for alignment and approval.
• Maintain compliance with GMP regulations, site procedures, and quality standards.
• Complete and maintain all required training within the Learning Management System.
• Utilize Pfizer document management systems and electronic quality systems as required