Senior/Consultant (Manufacturing Science and Technology)
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.
Professional Skills and Experience:
· 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 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.
· 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.)
Offering:
· Consulting roles with international healthcare clients in strategically relevant projects.
· Working in a professional consultancy environment together with a highly motivated team.
· Opportunity to take on leadership responsibilities and to help shape our organization.
· Excellent career development and growth opportunities in a growing premier consulting organization.
· Structured training program and peer mentoring system to support competence and personal growth.
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