QA Specialist

Headcount Solutions has been a leader in providing resourcing solutions in Project Management, Engineering, and Life Sciences sectors both in Ireland and internationally for over 20 years.

As a trusted provider of top engineering talent, we manage several client agreements under managed services, while also being a preferred supplier for resourcing needs across a variety of industries in both the public and private sectors, covering both contract and permanent roles.

We understand that people are your organization's most valuable asset. Our approach is centered on building strong, personalized relationships, drawing on our extensive experience to deliver the best talent to our clients.

QA 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.
• Experience working as a QA Specialist
• 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.