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QC Specialist II (MIS) #HMST
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EA License No.: 99C4599
3 months ago
Posted date
3 months ago
ChemicalJob category
Chemical
R1331820
EA Personal Registration No.
R1331820

Contract: 1 year

Location: Kranji

Working Hours: Mon – Fri 8.30am-6pm

Pay: 4-5.5k

 

Job scope

  • Project Management: Analytical, Raw Material and Microbiological Method Introduction
  • Project Management: Analytical Equipment Qualification
  • Regulatory Filing and Method launches
  • Invalid results tracking, trending and investigation
  • Unexpected results investigation
  • Control Trend establishment and investigations
  • Reference Standard and Reagent qualifications
  • Compendia review
  • Continuous Improvement
  • Audit Preparation and Involvement and other tasks as assigned.

 

Job requirements

  • Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
  • A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
  • Basic assay verification/validation know-how
  • Team player and independent contributor
  • DMAIC tools experience
  • Presentation skills for audits and validation teams
  • Experience in problem solving (facilitation and application of tools)
  • Basic statistical knowledge and experience with data analysis
  • Knowledge concerning cGMP, especially lab related topics as method validation life cycle, uunexpected results, critical reagent qualification
  • Basic knowledge about regulatory requirements concerning analytical test methods and licenses
  • Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
  • Knowledge in Microsoft Office
  • Project Management Skills
  • Communication and organizational skills
  • Strategically and Business oriented thinking
  • Good verbal and written communication skills

 

Interested candidates, do submit your resume in Word document to: biopharma@recruitexpress.com.sg

Whatsapp https://wa.me/6587514779

 

Jocelyn Chan          

Recruit Express Pte Ltd (Healthcare & Lifescience)          

Company EA Licence number : 99C4599          

Personnel EA License: R1331820

 

 

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JOB SUMMARY
QC Specialist II (MIS) #HMST
Singapore
3 months ago
Entry / Junior
Full-time