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Job ID :
58021BR
Location :
Singapore- Toh Guan Road
:
Job Description
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures, including local and international regulations applicable to clinical trials supply chain activities
  • Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments
  • Provide consultative guidance on regulatory matters to clients and internal associates
  • Responsible for liaisons with local and international regulatory bodies
  • Coordinate regulatory and submission activities for the following: importation/exportation of investigational medicinal products (biologicals/controlled substances/psychotropics/cytotoxics)/medical devices, local clinical trial import licences, GMP and GDP Certificates and related approvals/licences.
  • Maintain and updates all regulatory licences/certificates/approvals and related regulatory databases
  • To ensure that the inventory of supplies is accurately maintained with supporting documentation
  • Responsible for comparator drugs and ancillaries sourcing
  • Manage and coordinate all recall activities (internal/client initiated/regulatory initiated)
  • Prepare new and update existing job related Standard Operating Procedures (SOPs)
  • Conducts internal audits according to SOP requirement and assist in regulatory, supplier and client audits.
  • Perform pre and post review and approval of production batch records
  • Perform pre and post review and approval of label printing records
  • In-process inspection responsibilities for production and label printing jobs
  • Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
  • Assist in the QA/GMP training of employees across the company
  • Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
  • Perform ad-hoc duties as requested by line management


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