QA Supervisor
1 day ago
Summary
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that manufacturing operations and products meet specified standards. Develop conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Roles and Responsibilities- Lead QA on-site inspection related activities including monitoring the manufacturing process/documentation/computerized system to meet with procedure, GMP and data integrity requirements.
- Solve on-site manufacturing issue from QA perspective and ensure the process meets the standard operation procedure.
- Lead/follow/approve on-site inspection related deviation/investigation/CAPA to ensure they are reviewed, assessed, evaluated to comply with the cGMP.
- Liaise with Operation department/personnel to ensure regulatory and quality requirements are met during routine operations, enhance compliance awareness and further standardize operations in operation department.
- Lead cross-department/site/Kaizen project to ensure project smoothly running against schedule.
- Review and approve the related documentations including SOP, specification, manufacturing process, etc.
- Take part in internal and external audit, be responsible for audit response and implementing improvement.
- Supervise the subordinates including coaching and development.
- B.S. Degree in technical field, better major in pharmacy, food science, chemistry etc.
- Minimum 5-year experience in pharmaceutical industry or a medical device. Personnel with work experience in QA or QC is preferred.
- Thorough knowledge of national and international GMP requirements.
- Fluent English in speaking, listening, reading and writing.
- Proficiency in Microsoft Office Suite.
- Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behavior StatementWe expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.
Total Reward StatementOur total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Additional Information- Relocation Assistance Provided: No
- Locations - Location: Shanghai, Shanghai, China, 201203
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