As an Microbiology Subject Matter Expert you are tasked to Site SME in microbiological and sterility assurance, environmental monitoring program and cleanliness control strategies. Manage and lead a team of Micro QC Lab associates to perform inspection and testing of products to meet quality standard.
JOB SCOPE
- A Subject Matter Expect (SME) of Microbiological and Sterility Assurance test who will need to actively network with the internal and external scientific, technical and establish regulatory community to maintain state of the art knowledge.
- Establish company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, pure water systems and related areas.
- Provide micro-SME support to the site and assist in new product development and provide input in the design of manufacturing processes, water systems, controlled environments, and packaging from a microbiological standpoint.
- Have responsibility for the site environmental monitoring program and cleanliness control strategies.
- Work with cross-functional team to establish, validate and maintain clean manufacturing environments, processes, and utilities.
- Issue, conduct NCR and OOS investigation as a certified investigator, identify root cause and determine appropriate CAPA.
- Responsible for compliance to applicable Quality Regulations
- Lead a team of Microbiology associates and ensure microbiology inspection and testing activities are executed in compliant to SOP and regulatory requirements.
- Provide direction and supervision to direct reports.
- Lead and execute continuous improvement initiatives to improve productivity, efficiency, and cost optimization.
- Support internal and external audits and is responsible for audit finding closure, as required.
REQUIREMENT
- Min Degree in Microbiology
- Min 8 Years of experience in Microbiology lab and 3-5 years in a supervisory role in a manufacturing environment, preferably in medical or pharmaceutical field
