QA Senior Specialist

  Definition of Responsibilities   • Understand/interpretation of principal to drive improvement of process • Issue/risk identified   • Solve the problem and drive the improvement across function • Make quality decision - Quality review, approval, release • BPC (Business process champion) role • SME(Subject Matter Expert) • Team management     Management of QA affairs   1. Shop Floor quality management • Identify the quality risk during daily work, improve continuously. • Critical shop floor issue handling and decision 2. Quality issues handling • Qualified investigator to lead Major/Critical quality issue handling, investigation and assessment • Minor deviation approval 3. Product releaser 4. Business support and continuous improvement • Support PET business processes regarding compliance and quality • Drive continuous improvement in cross function • Lead team project/support cross team project 5. Inspections and audit • To be involved in regulatory inspections and self-inspection • Act as coordinator in regulatory or global audit if needed. 6. Perform and deliver quality activities assigned.     Quality systems management   1. Draft, review and approve GMP document to make sure in compliance with GMP requirement 2. Own QAF/Site procedure, secure operation GMP compliance 3. Quality assessment of cross function change and lead QAF change execution Quality continuous improvement Management • Lead daily work in each team • Work instruction and help to team members • Build and develop team capability • Provide daily performance feedback to team members SHE responsibilities • Identify and understand the SHE risk factors within the department. • Develop and carry out plans to address the key SHE issues in the associated areas and ensure the follow up actions are carried out.   Education, Qualifications, Experience and Capabilities 、 Essential  University graduate, major in pharmaceutical or related subjects 5 years of QA or production working experience - Desirable 理 8 years of QA working experience Have multiple national enterprise working experience Cross Function working experience  

职位描述