QC Lab Validation Engineer (Pharma/ GxP/ Systems) - #1087053

QC Lab Validation Engineer (Pharma/ GxP/ Systems)

12 Months Contract 

Location: Tuas 

Up to $8,000 depending on experience 

Industry: Pharmaceutical 

Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.

Responsibilities:

• Support the implementation and maintenance of QC GxP Systems in compliance with Sanofi Standards and Regulatory guidance, which includes:
• Write and/ or execute IQ and OQ test protocols for QC Laboratory Computerized systems/ electronic equipment, including writing of exception reports.
• Author Qualification Summary Report for QC Equipment.
• Author QC Systems associated procedures such as administrative SOPs and configuration specifications, as required.
• Provide user administration support to laboratory system, support user requests including troubleshooting and problem solving, as required.
• Partner with QC to conduct data integrity risk assessment.

Requirements:

• Bachelor’s or Master’s Degree in Pharmaceutical Sciences, related life Sciences or IT/ Technology with minimally 5-7 years of experience in QC and equipment validation.
• Good understanding of 21 CFR Part 11 and data integrity requirements.
• Experience in leading project to roll out GxP systems.
• Experience in writing and executing QC equipment test scripts.
• Subject Matter Expert in GxP applications and systems.

Lim Pey Chyi - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423