QC System Analyst (Pharmaceutical/ LIMS/ GxP/ 21 CFR Part 11)
Industry : Pharmaceutical
18-24 Months Contract
Location: Gul Circle
- Implementation of LIMS (Laboratory Information Management System) in QC, alongside with the following activities:
- Master Data Collection
- Write and execute LIMS IQ (Installation Qualification) Test Cases
- Write and execute LIMS UAT (User Acceptance Test)
- Write LIMS-related SOPs, including update/ revision.
- Conduct end user training.
- Support the implementation and maintenance of other QC GxP Systems.
- Provide user administration support to laboratory system, support user requests including troubleshooting and problem solving.
- Write and execute QC application software validation test scripts.
- Partner with QC to conduct data integrity risk assessment.
- Bachelor's or Master's Degree in Pharmaceutical Sciences, related life Sciences or IT/ Technology with minimally 3-5 years of experience in QC Systems.
- Good understanding of 21 CFR Part 11 and data integrity requirements
- Experience in leading project to roll out GxP systems
- Familiar with LIMS set-up and data structure
- Experience in writing and executing QC Systems test scripts
Lim Pey Chyi - Apple.firstname.lastname@example.org
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579