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You will be responsible for:
- Act as a Quality Assurance for the on-site team; ensuring documentation is filled out with the utmost adherence to Data Integrity and ALCOA++ principles.
- Fill out and review of qualification protocols for different work streams; including CTUs, Biosafety Cabinets (BSCs), Autoclaves, etc.
- Mentor and monitor a team of junior consultant in the documentation fill out and review of qualification protocols
- Knowledge of the main qualification tests to be performed for pharmaceutical systems.
- Report to Project Manager any encountered issues during the execution of the activity
About you:
- A minimum of 6 years of experience in construction quality management, preferably in pharmaceutical or industrial construction projects
- In-depth knowledge of CSA and MEP standards, regulatory requirements, and industry best practices.
- Strong understanding of regulatory requirements and industry guidelines (e.g., GMP, FDA, EMA).
- Strong leadership and problem-solving skills, with the ability to drive quality improvements across all phases of construction
- Hands-on experience with onsite inspections and contractor supervision.
- Excellent communication and interpersonal skills, with the ability to manage multiple stakeholders and resolve conflicts effectively.
- Fluent in English; Mandarin is a plus to liaise with Mandarin speaking associates.