Job Description

• Perform risk-based 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\xe2\x80\x99s degree in technical discipline such as Engineering or Science or with experience relevant to the .
• 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.

Interested candidates can forward their CVs in MS Word format to connie@triton-ai.com
Reg No. R1875181
Triton AI Pte Ltd
License no. 21C0661

Benefits:

• Permanent Role
• Up to $6,500 + 2 months VB
• Working location: West MRT
• Pharmaceutical Industry Experience is a MUST
• Aseptic technique for QC candidates
• CIP, SIP experiences will be preferred