- Singapore
ANTER CONSULTING PTE. LTD. Hiring! Full Time QC Qualification Engineer (Laboratory Analytical Computerised Systems) in , Earn up to SGD 8,600 - Ricebowl
QC Qualification Engineer (Laboratory Analytical Computerised Systems)
ANTER CONSULTING PTE. LTD.
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Job Description
Responsibilities
A global biopharamceutical company is preparing for an upcoming project and is looking for a QC Qualification Engineer to join its Quality Control team on a 12-month contract starting January 2027. You will own the qualification lifecycle of laboratory analytical computerised systems, working closely with F&E, QA, QC and IT.
Key Responsibilities
Support change control initiation and take end-to-end ownership of change controls for laboratory analytical computerised system qualification
Draft and execute validation documents: Validation Plan and Requirements, IOQ/PQ test scripts, summary reports and Data Integrity Risk Assessments
Draft system decommissioning documents (decommissioning plan and summary report)
Draft Operations and Maintenance SOPs
Support the generation of the Preventive Maintenance program for the system
Coordinate with equipment vendors on vendor qualification activities
Work with F&E, QA, QC and IT stakeholders to keep activities on schedule
Requirements
Bachelor’s degree in Science, Engineering or a related field
Hands-on experience in laboratory equipment qualification
Working knowledge of lab instruments, computerised system validation and controlled temperature chamber qualification
Strong understanding of validation approaches, strategies and philosophies
Experience with change control methodology
Good knowledge of data integrity, GMP and GDP
Experience in a biotech or pharmaceutical environment preferred
Experience with KNEAT or other electronic validation tools preferred
Familiarity with any of the following is a bonus: Charles River endotoxin readers, Agilent Epoch 2 microplate readers, Beckman Coulter acoustic liquid handlers
Good interpersonal and communication skills, and a collaborative team player
Strong focus on safety, quality and timelines
Able to work independently with minimal supervision
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.
Key Responsibilities
Support change control initiation and take end-to-end ownership of change controls for laboratory analytical computerised system qualification
Draft and execute validation documents: Validation Plan and Requirements, IOQ/PQ test scripts, summary reports and Data Integrity Risk Assessments
Draft system decommissioning documents (decommissioning plan and summary report)
Draft Operations and Maintenance SOPs
Support the generation of the Preventive Maintenance program for the system
Coordinate with equipment vendors on vendor qualification activities
Work with F&E, QA, QC and IT stakeholders to keep activities on schedule
Requirements
Bachelor’s degree in Science, Engineering or a related field
Hands-on experience in laboratory equipment qualification
Working knowledge of lab instruments, computerised system validation and controlled temperature chamber qualification
Strong understanding of validation approaches, strategies and philosophies
Experience with change control methodology
Good knowledge of data integrity, GMP and GDP
Experience in a biotech or pharmaceutical environment preferred
Experience with KNEAT or other electronic validation tools preferred
Familiarity with any of the following is a bonus: Charles River endotoxin readers, Agilent Epoch 2 microplate readers, Beckman Coulter acoustic liquid handlers
Good interpersonal and communication skills, and a collaborative team player
Strong focus on safety, quality and timelines
Able to work independently with minimal supervision
At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.
We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.
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