quality assurance in Singapore

posted
contact
rachel ren, randstad
job type
permanent
apply now

job details

posted
location
singapore
specialism
life science
job type
permanent
working hours
Full-Time
experience
3 years
reference number
91M0130648_1553411737
contact
rachel ren, randstad
apply now

job description

about the company
A fast-growing multinational pharmaceutical company focused on developing cutting-edge drugs for the treatment of a niched range of disorders.

about the job

You will report to your Chief Executive Officer, and be responsible to design and establish a Quality Management System (QMS) in accordance with FDA CMC and GLP guidelines. You will:

  • Write and review QMS related documentation such as SOPs, protocols and manuals.
  • Ensure that appropriate and technically valid SOPs are established, approved and followed.
  • To establish and manage an archive system for QMS related documents, including indexing and filing of existing and superseded documentation.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 studies carried out in the facility.
  • Perform Risk Assessments, write and execute validation protocols to qualify, validate and maintain laboratory equipment such as the HPLC.
  • Write and review protocols for method validation. Experience with GMP is a plus.


skills and experience required

  • Post-graduate qualifications in Pharmacy, Chemistry or related discipline.
  • Proficient with GxP and FDA CMC requirements, with at least 3 years of working experience with an accredited facility.
  • Good communication skills.



To apply online please use the 'apply' function, alternatively you may contact Rachel at 6510 1338.
(EA: 94C3609/ R1767439 )





skills

no additional skills required

qualification

no additional qualifications required

educational requirements

Bachelor Degree