Role Summary: This position involves working within the QA department to facilitate the carrying out of QA activities, which include the review of key documentation to support product release.
Essential Responsibilities: 1. Reviewing of production documentation and assisting with batch release procedures 2. Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations 3. Supporting the ongoing deviation / corrective action program 4. Liaising with other departments to allow closure of corrective actions 5. Participating in audits, together with follow up. 6. Responding to routine quality related queries from other departments 7. Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP. 8. training of Operations personnel 9. Support the timely release of product to market. 10. Conducting QA activities including revision of SOPs, SAP QA work and the issuance of protocols. 11. Review, Approval and Reporting Activities related to the QMS 12. Attending a number of cross functional team meetings / projects
Qualifications/Requirements: 1. B.S. Degree in business or technical field or equivalent experience 2. 1-year experience in a medical device or pharmaceutical industry. 3. 1-year experience with CA/PA systems, including complaint handling. 4. Thorough familiarity with cGMPs of sterile product manufacture 5. Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages
Desired Characteristics: 1. Statistics education and or training 2. Experience developing and tracking quality metrics 3. Familiar with Continuous Improvement methodologies, including Six Sigma
About Us: GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com Additional Locations: China;ShangHai;Shanghai;
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