Qc Analyst

1 week ago

Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time

Responsibilities:

  • Supports team task to enable adequate resources to support laboratory infrastructure (E

g:
Equipment, Method, System) needs

  • Participates in the management of laboratory equipment and IT systems in QC laboratory to ensure business continuity and system data maintenance, equipment maintenance/calibration is in a state of compliance
  • Participates in method technology transfer and laboratory equipment technological refresh/introduction activities into QC Laboratory within project timeline
  • Participates in QC laboratory long range planning to ensure laboratory infrastructure needs is secured and Data integrity plan is in place to support business and laboratory compliance
  • Author or Review (If assigned) method transfer/qualification and equipment qualification documentation (E

g:
Reports, Protocol, change control, related quality documents or procedures) are in cGMP compliance to corporate/site or regulatory requirements

  • Supports and ensure timely escalation/handling of lab events or related quality actions. (E

g:
NCR, Lab Investigation, CAPA)

  • Acts as QC SME/ Supports preparation and participate in internal/external audit, audit responses, to enable a successful audit outcome
  • Participate in EHS, Business Compliance, cGMP and all other compliancerelated matters, where applicable. Lead/supports CI initiatives to enable laboratory performance metrics
  • Carry out any other task as assigned by Supervisor

About You:

  • University Degree in Science related discipline (e.g. chemistry, biology, pharmaceutical sciences, or equivalent experiences)
  • Minimum 4 years of pharmaceutical experience in a Quality Control Function
  • Experienced in Regulatory/ Pharmaceutical requirements
  • Analytical thinking with problem solving and writing skills
  • Motivated and independent
  • GMP knowledge on QC Lab Equipment and Method transfer
  • Good communication skills and Strong ability to work cross functional teams
  • Ability to work towards timeline

Job Type:
Contract

Contract length: 12 months

Salary:
$3, $5,500.00 per month

Experience:

  • Regulatory/ Pharmaceutical: 2 years (preferred)
Quality Control Function: 2 years (preferred)

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