Job Description 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.
Job Description
Roles and Responsibilities
- Lead day to day QA activities including deviation/OOS/complaint handling to meet with procedure and GMP requirements.
- Approve deviation/OOS/CAPA to ensure they are reviewed, assessed, evaluated to comply with the cGMP.
- Coordinate with QP/LD to assess the impact of deviation/OOS to the product release/shipment; align with shipping requirements to coordinate the closure of deviation/OOS or the disposition of product.
- Approve complaint/ADR to ensure they are investigated according to cGMP and procedures. Coordinate with commercial/market/PV team to solve customer's concern/query on product quality.
- Lead cross-department/site/Kaizen project to ensure project smoothly running against schedule.
- Review and approve the GMP related documentations including SOP, specification, manufacturing process, etc.
- Take part in internal and external audit, be responsible for audit response and implementing improvement.
- Assist QA routine departmental activities including quality monthly report, annual product review, training, etc.
- Supervise the subordinates including coaching and development.
Required Qualifications
- 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.
Desired Characteristics
- Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
Inclusive Diversity Paragraph
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 Statement
We 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 Statement
Our 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 you'd expect from an organization with global strengthand scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
**Additional Information*
*Relocation Assistance Provided:
No