Critical Support Roles
Job Summary
This position is accountable for providing effective microbiological and analytical services to ensure that Microbiological procedures and requirements are met within a state-of-the-art Biologics Sterile Fill-Finish liquid and lyophilized product facility.
The key responsibilities include facilitating the facilities sterility assurance program, overseeing microbiological and analytical services, and enforcing quality systems to guarantee compliance with industry standards and regulatory requirements.
Main Duties and Responsibilities:
1. Establish, implement, and maintain the facilities sterility assurance program.
2. Define, update, and enforce standard operating procedures (SOPs) related to microbiological services.
3. Liaise with regulatory and corporate inspectors/auditors to ensure compliance with guidelines and policies.