Ivan Yu

Ivan Yu Email and Phone Number

QA Operations Manager @ Amgen
Singapore
Ivan Yu's Location
Singapore, Singapore
Ivan Yu's Contact Details

Ivan Yu work email

Ivan Yu personal email

n/a
About Ivan Yu

Experienced QA professional with a demonstrated history of working in the pharmaceutical industry. Strong skills in GMP and Quality Management Systems..

Ivan Yu's Current Company Details
Amgen

Amgen

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QA Operations Manager
Singapore
Website:
amgen.com
Employees:
35769
Ivan Yu Work Experience Details
  • Amgen
    Qa Operations Manager
    Amgen
    Singapore
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  • Amgen
    Specialist, Manufacturing Support Qa
    Amgen Feb 2022 - Present
    Singapore
    Operations QA
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  • Amgen
    Specialist, Quality Management Systems
    Amgen Jul 2019 - Present
    Deviations, CAPAs, Complaints, Recall & Document Management SME
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  • Amgen
    Specialist Quality Compliance
    Amgen Apr 2017 - Jun 2019
    Singapore
    Audits and Inspections SME
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  • Amgen
    Senior Associate, Quality Compliance
    Amgen Nov 2015 - Mar 2017
    Led Inspection Prep Room for successful EMA and FDA facility Pre-Approval Inspection
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  • Merck
    Senior Quality Associate (Quality Systems & Compliance)
    Merck Jan 2010 - Oct 2015
    Singapore
    Site lead for Change ManagementLead and coordinate change controls to ensure alignment of regulatory filings with experience in APIs and Sterile Products.Tracking and recording of activities associated with regulatory submissions.Provide support to licence holder and liaise with local authorities pertaining to licence application/renewalSupport Global Regulatory Affairs with submissions and processing of post-approval changes.Conduct internal audits for site facilities.Manage audits by health authorities and customers.
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  • Merck Sharp & Dohme
    Quality Associate (Release)
    Merck Sharp & Dohme Feb 2006 - Dec 2009
    Quality Associate in Product Release, Singapore Biotech Facility.Release of both raw materials and finished products.SAP UserLIMS Superuser.SAP-LIMS Interface Project TeamProject lead in cost-savings initiative which led to US$500,000 annual savings.
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  • Stella Chemifa
    Chemical Engineer
    Stella Chemifa Jun 2004 - Feb 2006
    Section Head of Refining.Led team of 16 technicians.In charge of all issues pertaining to daily operations such as material planning, purchasing, engineering and maintenance works & shift planning

Ivan Yu Skills

Sap Gmp Sales Biotechnology Change Control Regulatory Affairs Validation Medical Devices Quality Assurance Compliance Quality System V&v Regulatory Submissions Pharmaceutical Industry Technology Transfer Lims Capa Fda R&d

Ivan Yu Education Details

Frequently Asked Questions about Ivan Yu

What company does Ivan Yu work for?

Ivan Yu works for Amgen

What is Ivan Yu's role at the current company?

Ivan Yu's current role is QA Operations Manager.

What is Ivan Yu's email address?

Ivan Yu's email address is iv****@****orp.com

What schools did Ivan Yu attend?

Ivan Yu attended National University Of Singapore.

What skills is Ivan Yu known for?

Ivan Yu has skills like Sap, Gmp, Sales, Biotechnology, Change Control, Regulatory Affairs, Validation, Medical Devices, Quality Assurance, Compliance, Quality System, V&v.

Who are Ivan Yu's colleagues?

Ivan Yu's colleagues are Paul S., Tashara Marie Monteil, Bs, Suzanne Skutca, Cpc, Haider Khan, Yildirim Beyazit, Mateusz Preś, Yuyang Zhang.

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