Qc System Analyst (pharmaceutical/ Lims/ Gxp/ 21 Cfr Part 11)
Gul, Singapore, Singapore
Job Description
Industry : Pharmaceutical
18-24 Months Contract
Location: Gul Circle
Responsibilities
- 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
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579
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Job Detail
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Job IdJD1379755
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:$4000 - 5000 per month
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Employment StatusPermanent
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Job LocationGul, Singapore, Singapore
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EducationNot mentioned