Job Title: Quality Assurance Specialist - Compliance and Operations Support
Description: Our client, a leading industry player, is seeking a Quality Assurance Specialist to join their team. The successful candidate will be responsible for ensuring the quality and compliance of products and manufacturing processes.
Key Responsibilities:
- Ensure all products meet required standards for marketed and investigational drug products.
- Conduct audits and reviews of completed batch records, manufacturing logs, and quality documentation (SOPs, JSTMs, Risk Assessments).
- Lead investigations into product or manufacturing process non-compliance.
- Provide stability program support and administer quality logs.
- Drive continuous improvements and simplify site processes and procedures to maintain compliance.
Requirements:
- Third-level degree in a science, quality, or engineering discipline.
- Previous experience in a quality role, ideally with a minimum of three years' experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
About the Role: This is an exciting opportunity to join a dynamic team and contribute to the success of our client. If you have a strong background in quality assurance and compliance, we would like to hear from you.