Supports Sterilization validations (EO and irradiation) for Penang Site.
Supports Sterilization regulatory and compliance activities at Penang Site.
Supports Sterilization submissions to regulatory bodies.
Key Sterilization person at sites during external audits.
Key role in conducting audits of Sterilization vendors and facilities.
Liaise with Contract sterilization providers in addressing deviations and/or downtime.
Regular communication with Global Sterility Assurance Organization.
Compliance to internal BSC procedures and GMP practices.
Good knowledge of MDD and FDA requirements.
Good knowledge of EO E-Beam and Gamma Sterilization.
Knowledge of Sterilization and Quality System Standards.
Plans and coordinates sterilization evaluations requests from Penang site.
Management and preparation of dunnage's for sterilization activities
Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in sterilization and applies this knowledge in leadership roles in the company.
Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
Serves as a resource in the orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance.
Job Requirements:
Candidate required process at least Bachelor Degree in science/engineering.
At least 2 -5 years of working experience in related field.
Knowledge: EO/irradiation/E-Beam sterilization, cGMP, Combination Device Regulations and other Sterilization related regulations.
Candidate from medical industry will be preferable.