Qc Analyst - Singapore - NUSANTARA PRIME CONSULTING PTE LTD

NUSANTARA PRIME CONSULTING PTE LTD

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

beBee Recruiter

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