Senior Consultant

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.