QA Auditor conducting various quality assurance audits at Syneos Health. Preparing for regulatory authority inspections and mentoring less experienced QA auditors.
About the role
- QA Specialist responsible for evaluating and reviewing clinical and commercial drug batches at Pfizer. Ensuring quality compliance and supporting manufacturing operations teams in Ireland.
Responsibilities
- Evaluate and review Pfizer’s clinical and commercial batches of drugs
- Ensure product and process documents match specifications
- Identify deviations from established standards
- Approve investigations and change control activities
- Complete walkthrough audits to ensure cGMP compliance
- Review and approve validation documents and master batch records
- Report batch deviations in accordance with corporate standards
- Assist in the creation and maintenance of QA policies and SOPs
- Support new product introduction and continuous improvement projects
Requirements
- Relevant Third Level Qualification or Equivalent
- Minimum 2 years experience in a QA/QC GMP environment in a Pharma/Biotech company
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team in a fast-paced environment
- Proactive approach and strong critical thinking skills
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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