Specialist – QA

Specialist – QA

Requirements

• Bachelor’s degree in science or engineering
• 5 years of experience in pharmaceutical/biological manufacturing
• Demonstrated knowledge of quality compliance in GMP-regulated environments (5 years)

Responsibilities

• Provides coaching and leadership to shopfloor staff, assuring that processes are executed effectively, compliantly and thereby enabling and promoting a Quality culture.
• Partners with production and operates with strong process knowledge and risk-based decision making, required on the shopfloor to support cGMP compliance.
• Responsible for timely and thorough deviation investigations, guiding the investigation team as required throughout the investigation process (problem definition, scope, investigation strategy, RCA, CAPAs) and ensures that batch decisions are compliance and science-based, and supported by strong data driven justification.
• Ensures timely review and approval of deviations, SOPs, CAPAs, ERs and other GxP documents such as Master Batch Production Records, operational log books, sterilization and depyrogenation records, work orders, worksheets, maintenance task lists, change control assessments and approvals, and protocols/ reports that are within the scope or delegated.
• Participates as QO Representative at various committees and boards such as: Sanofi Pasteur Change Control Board, Deviation Review Board, +QDCI, FFast, etc.
• Participates in self-inspections, periodic internal reviews/audits to ensure compliance procedures are followed, and participates in external audits/inspections Identifies and mitigates risks, and leads Shopfloor Quality improvement within the APT and more broadly as applicable.
• Ensures alignment to Global and new Regulatory requirements, participating in gap remediations, compliance and Site Projects as required.
• Support the OQ Deputy Director (as required) in the following (but not limited to) assessing and approving Process at Risk (PAR) forms, Provision batches in the eBAR for financial month end.

Preferred Qualifications

• Engineering/maintenance experience preferred
• Quality Control experience preferred