Validation & Qualification Engineer (Cip & Sip - Singapore - Triton AI Pte Ltd

Triton AI Pte Ltd

Verified Company

Singapore

6 days ago

Posted by:

Wei Jie

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Job Description

Responsibilities:

Perform riskbased commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on Process Equipment, CIP / SIP, Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations, Method validation (analytical chemistry, biochemistry, microbiological) & Enterprise system (LIMS, QMS).
Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.
Develop validation protocols using a science and risk based approach that meets regulatory requirements and industry best practices.
Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
Investigate deviations, write investigation reports and create summary reports.
Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Requirements:

Bachelor's degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description.
Minimum 3 years of experience in pharmaceutical industry
Experiences in commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer.
Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred
Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system.
Designing and conducting test methods validation (sterility test, disinfectant test, et
Strong knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.

Reg No. R1549345
Triton AI Pte Ltd
License no. 21C0661