LIMS QC Specialist (Pharmaceutical/ GxP/ 21 CFR Part 11)

LIMS QC Specialist (Pharmaceutical/ GxP/ 21 CFR Part 11)

9 Months Contract

Location: Tuas

Up to $7,000 depending on experience

Industry: Pharmaceutical

Responsibilities:

• Implementation of LIMS (Laboratory Information Management System) in QC, alongside with the following activities:

1. Master Data Collection
2. Write and execute LIMS IQ (Installation Qualification) Test Cases
3. Write and execute LIMS UAT (User Acceptance Test)
4. Write LIMS-related SOPs, including update/ revision.
5. 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.

Requirements:

• 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
• Familiar with LIMS set-up and data structure
• Experience in writing and executing QC Systems test scripts
• Excellent interpersonal relationships and good communication skills to establish the partnerships with key stakeholders.

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423