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Senior / Consultant (manufacturing Science And Technology) - Singapur, Singapore - Nityo Infotech
Description
At least Bachelor's degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply. · 3 or more years of experience in several functions in pharmaceutical industry: commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer. · Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI and other regulatory requirements preferred · Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions. · Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices. · Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline. · Preferred to have experience interacting with or creating material for management and regulatory agencies. · Ability to communicate quality and risk-related concept to technical and non-technical audiences · Good organizational skill and ability to work independently · Good written and oral communication skills, presentation, and data analytics with center of excellence · Demonstrated ability to work as both a team player and independently · Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail · For candidates from QC background, prefer to have experience in one or more of the following areas: o Good Aseptic technique. o Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system. o Designing and conducting test methods validation (sterility test, disinfectant test, etc.)Experience Required
3 - 7 Years
Industry Type
IT
Employment Type
Permanent
Location
Malaysia
Roles & Responsibilities
Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas: o Process Equipment o CIP / SIP o Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations o Method validation (analytical chemistry, biochemistry, microbiological) o 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.
Expertise & Qualification
At least Bachelor's degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply. · 3 or more years of experience in several functions in pharmaceutical industry: commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer. · Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI and other regulatory requirements preferred · Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions. · Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices. · Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline. · Preferred to have experience interacting with or creating material for management and regulatory agencies. · Ability to communicate quality and risk-related concept to technical and non-technical audiences · Good organizational skill and ability to work independently · Good written and oral communication skills, presentation, and data analytics with center of excellence · Demonstrated ability to work as both a team player and independently · Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail · For candidates from QC background, prefer to have experience in one or more of the following areas: o Good Aseptic technique. o Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system. o Designing and conducting test methods validation (sterility test, disinfectant test, etc.)
