We are seeking an Associate Specialist, Quality Assurance to ensure our drug product manufacturing process complies with cGMP and regulatory requirements. You will review and approve GMP documentation, support corporate compliance, and ensure a reliable supply to our customers. This is a Shift IPT Role, with shift patterns to be discussed.
Principal Accountabilities:
- Review and approve manufacturing batch documentation, SOPs, and validation data.
- Provide real-time quality oversight and support for manufacturing operations.
- Provide training in Quality Management Systems and GMP.
- Drive compliance with global policies, regulatory requirements, and cGMP.
- Facilitate continuous improvement of the Quality Management System.
- Partner cross-functionally to provide support and advice on various quality-related matters.
- Initiate and maintain quality-related metrics.
Skills and Knowledge:
- Third Level Degree in a Science/Technical or related discipline.
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of US and European cGMP guidelines.
- GMP Audit experience.
- Strong problem-solving, communication, and decision-making skills.
- Report and policy writing skills.
