QA Specialist III
QA Specialist III
China - Shanghai
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences is currently seeking a QA Specialist III located at China affiliate in Gilead Shanghai commercial office. This position will be the QA Specialist III supporting quality activities at affiliate level, and responsible for administration of quality activities in Affiliate Quality and compliance in the general operation at the Gilead office.
- Provides functional hands on quality supporting to product complaint management at affiliate level to ensure that business and quality objectives are met.
- Follow quality principles to ensure effective compliance of the affiliate quality system with Gilead policies, processes and procedures and all applicable regulations and industry standards, including creating and maintenance of local procedures, work instructions, records and all applicable quality system documents
- Participation in the audits in support of the affiliate.
- Lead the investigation of quality events at the affiliate level such as quality discrepancy of shipments and products to/in the markets in compliance with global and local procedures.
- Documents support/management on the activities in relation with shipment, internal and external quality audit, quality agreement, routine visit to distributor, package material, product market actions, training record, etc., as applicable at affiliate level.
- Ensures all GMP/GSP documents including SOPs/records in affiliate are maintained in compliance with the Gilead and local regulatory requirement.
- Prepare and consolidate quality reports including presentations for Affiliate Quality (especially for quality analysis/trend, quality documents/records and follow up the execution of action plan, etc.);
- Training support/management for all staffs at affiliate level.
- Communicate with internal and external customers on all quality and compliance-related matters
- Assist the Affiliate Quality on project execution and administration, for example: prepare Service/PO/Contract approval; document various aspects of the projects according to the project management procedures.
- Coordinate Affiliate Quality team meetings and other administrative activities (propose agenda & venue, track progress on actions, take minutes);
- Make arrangement for Affiliate Quality Team and quality visitors in area of meetings, events, travels, transportation, hotel arrangement, reimbursement, visa, business card etc.);
- Ad-hoc tasks assigned by line manager.
- Occasional trips to activities needed.
Knowledge, Experience and Skills
- 8+ years of relevant experience in the pharmaceutical industry.
- 5+ years of experience on the QA for drug products at manufacture site.
- Experience on creating/maintaining the GMP/GSP documents/SOP, leading the quality investigations at the affiliate level.
- A BS degree in pharmacy or relevant areas.
- Licensed pharmacist is preferred.
- Good communication skill, expression ability and teamwork spirit.
- Have CET6 or above, and proficiency in both spoken & written English.
- Advanced knowledge of MS Excel, Work, PowerPoint
- Able to work independently
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/China---Shanghai/QA-Specialist-III_R0019849
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