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Job Description
Quality Assurance Specialist responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in aseptic processing and manufacturing.
Key Responsibilities:
- Ensure all products meet quality and regulatory standards.
- Provide quality oversight and assistance to Operations function.
- Lead investigations into product or manufacturing process non-compliance.
- Review and audit batch records and manufacturing logs.
- Complete quality reviews of operations documentation and line clearance activities.
- Perform incoming raw material checks and maintain product status.
- Provide stability program support and maintain finished product status.
- Administer quality logs and lead daily walk arounds of manufacturing areas.
- Drive continuous improvements and simplify site processes.
Requirements:
- Third-level degree in science, quality, or engineering discipline.
- Previous experience in quality role, ideally in a GMP environment.
- Minimum three years' experience in quality/operations role in a highly regulated environment.
- Strong knowledge of regulatory requirements.