My client is a global name in the biopharma industry and now seek an experienced Quality Assurance Specialist to join them.
- Establish, maintain, and improve laboratory QMS system according to FDA, CMC/HSA and GLP guidelines
- Review and implement QMS related documentation such as SOPs, work instructions, lab protocols and manuals
- Train staff on relevant QMS activities
- Ensure that valid SOPs are established, approved, and followed
- Establish and manage an archive system for QMS related documents
- Manage a master scheduler for all activities and supporting studies carried out in the facility
- Conduct due diligence on and manage contractors and third party suppliers
- Perform risk assessments, manage and execute validation schedules and protocols
- Degree/Masters in Pharmacy, Chemistry, or equivalent
- At least 5 years' of experience in a QA/Lab role
- Proficient with GxP and FDA CMC Requirements
- Stronghold in ISO 90001 and 17025
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).