Responsible for designated quality assurance and quality control activities.
To take an important role of Quality in monitoring operation activities to ensure that clinical trial supplies are handled and facility are maintained in accordance with established procedures and GxP standards.
Perform QC inspection of incoming goods according to FCS procedure and client specific requirement. Responsible for the release of incoming goods supplied by clients or FCS other sites or external vendors. To check the accuracy of returned goods and supporting documentation. Perform daily check for operation activities in warehouse to ensure their compliance with GMP/GDP, client requirements and local SOPs. Manage the pest control devices in FCS Beijing facility, and perform periodic trend analysis. Assists in the investigation of internal non-conformances through to resolution where required. Monitor cold chain management, including shipper qualification report review, Approved Shipper List update, and coolPacs conditioning. Management of validation/qualification system. Review and approve validation protocol and report as the QA representative. Perform periodic validation history review. Conduct internal audits according to SOP requirement and assist in regulatory and client audit. Perform ad-hoc duties requested by line management.
Education: Bachelor degree in life science, chemical or pharmaceutical/medical related.
Years of Experience: >5 yrs quality assurance or quality control working experience; 1-2 yrs working experience in pharmaceutical industry; experience in production or manufacturing field of life science will be privileged.
Knowledge: Advanced understanding and grasp of quality management, GxP, preferably the knowledge of clinical trial materials. Knowledge in supply chain or warehouse operation will be plus.
Competency: Good communication skills. Good written and spoken English. Problem Solving/Decision Making. Details-oriented.
Bachelor degree 5 yrs relevant working experience Quality knowledge and GxP knowledge