laboratory quality assurance (qa) specialist in Singapore

posted
contact
rachel ren, randstad
job type
permanent

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
experience
2 years
reference number
91M0152127_1610432630
contact
rachel ren, randstad
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job description

about the company

A global leading Contract Research Organisation (CRO) that provides preclinical and manufacturing support QC services.


about the job

  • Design and establish a Quality Management System (QMS) in accordance with FDA CMC, GMP, and GLP guidelines
  • Write and review QMS related documentation such as SOPs, protocols and manuals
  • Ensure that appropriate and technically valid SOPs are established, approved and followed
  • Establish and manage an archive system for QMS related documents, including indexing and filing of existing and superseded documentation
  • Establish a Master Schedule for all activities supporting GLP and GMP studies carried out in the facility
  • Perform Risk Assessments, write and execute validation protocols to qualify, validate and maintain laboratory equipments



skills and experience required

  • Degree in Pharmacy, Biology, Chemistry, or related discipline
  • Proficient with GxP and FDA CMC requirements, with at least 2 years of working experience with an accredited facility


To apply online please use the 'apply' function.
(EA: 94C3609/ R1767439 )

skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree