Job Details

Job Type
Gilbert Khor
Contact email
Email Gilbert
Contact phone
65 6692 0742
29 days ago
Based in Singapore
Analytical Science & Technology
Biopharmaceutical Sector

The position will get the incumbent involved and leading in the analytical technology transfer of biologics or biopharmaceutical quality control processes. The company will be relying on the incumbent in providing the technical expertise and consultation to the team on the ground.

Key Responsibilities:

  • Participates and supports GMP audits
  • Leads and manages site projects and initiatives
  • Keeps up-to-date on the regulations/ development concerning biopharmaceutical QC activities to ensure quality control operations are in compliance to applicable corporate, regulatory and external agency regulations and guidelines
  • Supports the manager to ensure knowledge retention and effective training within team
  • Ensures all in-use procedures are current and compliant
  • Writes/ reviews/ approves required GMP documentations such as SOP, protocols, reports
  • Writes/ reviews/ approves notifications (events and deviations) and/or CAPAs
  • Writes/ reviews/ approves changes (CCs)
  • Leads/ manages investigation of non-conformities (NC) (events and deviations)
  • Ensures thorough investigation and timely closure with effective CAPA to prevent recurrence
  • Provides guidance, support and technical expertise on quality control operations (relevant to area of responsibility) to ensure full compliance to any regulatory guidelines
  • Manages local compendium system
  • Ensure team performance and efficiency
What we are looking for:

  • Relevant Degree in Science (Chemistry/Biochemistry/Microbiology)
  • Relevant working experience in a testing laboratory or Bio/pharmaceutical environment 
  • Technical knowledge and competencies for method validation and qualification
  • Technical knowledge on analytical + sampling method validation around cleaning validation
  • Strong analytical mind set
  • Good communication skills 
  • Good knowledge of cGLP and cGMP
  • Proven leadership skills with good interpersonal skills and stakeholder management