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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Establish and manage an archive system for QMS related documents, including indexing and filing of existing and superseded documentation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 )

no additional skills required

no additional qualifications required

Bachelor Degree