QA Compliance Specialist

Responsibilities
• Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
• Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
• Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
• Review/Audit of completed Batch Records.
• Review of Manufacturing Logs as required.
• Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)

Requirements
• Third level degree in a science, quality or engineering discipline.
• Ideally previous experience in a quality role
• A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
• Experience in aseptic processing gained within either a quality or operations role is highly desirable.
• A strong knowledge of regulatory requirements is required.