Our client is a Global Leader in Medical Technology. They are seeking an experience Sterilization and Microbiology Manager.
- Manager the sterilization and microbiology team and processes to ensures compliance to FDA, PMDA regulations and ISO 13485
- Review the qualification, improvement, maintenance, and other activities related to sterilization process, and microbiology laboratory process.
- Provides support to production for any technical issue and other activities such as Nonconformity management, CAPA,
- Support, review and approve processes : Document updates , Facility maintenance procedures and Corrective / Preventive Actions
- Participate in the Global Sterilization & Microbiology committee and standardization, and lead the site implementation
- Bachelor Degree in relevant Science Disciplines
- Minimum 7 years’ experience in Microbiology or Sterilization or Quality Assurance function in the Regulated manufacturing environment
- Good communication and interpersonal skills, ability to articulate ideas clearly and concisely to people of all levels.
- Preferably experience in EO Sterilization, and/or Bioburden / Endotoxin testing
GMP TECHNOLOGIES (S ) PTE LTD | 11C3793
EVE LIM | R1113354