BD (Becton, Dickinson and Company) 高级验证工程师_QA_宜兴_宜兴工厂 in Suzhou, China
Job Description Summary
Take the responsibility of site validation leader for ensuring site qualification and validation activities meet relevant QMS requirements and GMP requirements. And also involve in quality system set-up and maintenance.
KEY RESPONSIBILITIES （主要职责）
Set-up validation master plan (VMP) for greenfield factory
Set-up qualification and validation management procedure to ensure all facilities/utilities/equipment qualification, computerized system, process validation, cleaning validation, MSA are implemented comply with GMP requirements and headquarter policies.
Organize the qualification and validation implementation and supervision the qualification and validation activities. Responsible for Validation resources management.
Support for change control process for evaluating of qualification and validation status.
Review process FMEA as necessary.
Establish and maintain calibration program with compliance to related regulation and equipment/instrument user requirement.
Involve in set-up and maintenance quality system.
Be engaged with design control process to develop process validation strategy.
Review and approve validation deviation/discrepancy as required.
EHS compliance in the responsible area.
Other superior assigned work.
SKILLS AND ABILITIES （技能）
Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic.
At least 3 years relevant work experience of validation experience in medical devices or drug companies
Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements
team player with well communicative and cooperative,
Knowledge of Six Sigma for Manufacturing, Knowledge of analytical and statistical tools
六西格玛知识和分析和统计工具知识 Fluent in listening and speaking in English and Chinese
Primary Work Location
CHN Suzhou - Plant 1
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.