About the role
AI summarisedJoin the Quality Assurance team at Thermo Fisher Scientific to ensure consistent execution of quality standards and regulatory compliance within a GMP environment. You will play a vital role in enabling breakthrough discoveries by driving continuous improvement initiatives and maintaining the highest standards of quality across all site operations.
Life SciencesOnsite
Key Responsibilities
- Write relevant procedures and review SOPs from other functional teams.
- Maintain the QMS system (e.g., TrackWise, eDMS) to support GxP compliance and author SOPs/Work Instructions.
- Maintain the site change control system, evaluating changes to ensure appropriate control and impact assessment on product quality.
- Manage the site CAPA system, including designing effective actions and overseeing effectiveness checks to ensure timely closure.
- Manage corporate standards gap assessments at the site level to ensure compliance with regulatory requirements.
- Maintain document and record management systems, overseeing execution compliant with site management requirements.
- Execute site self-inspection programs to ensure compliance with cGMP and corporate policies.
- Coordinate inspection readiness activities for client and regulatory audits, and participate in hosting audits.
- Support the site management review process by collecting data, analyzing trends, and driving continuous improvement.
Requirements
- Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area.
- 1-3 years of relevant Quality experience in pharmaceuticals preferred.
- Knowledge in cGMP and Regulatory Compliance.
- Proficiency in GMP Quality Management System principles.
- Effective problem-solving skills and knowledge of Quality Risk Management tools.
- Strong systematic thinking, communication, coordination, and collaboration abilities.