Guarantee that safety remains our top priority and is lived throughout the organization.Develop and maintain the Contamination Control Strategy (CCS) for the site, ensuring compliance with regulations.Coordinate maintenance activities within the sterility assurance department to minimize environmental contamination and product risk.Collaborate with the investigation team to manage quality events impacting sterility and evaluate deviations and complaints.Review and approve major deviations and corrective/preventive actions related to sterility assurance.Contribute to the development and revision of SOPs impacting sterility assurance and evaluate necessary changes.Analyze data from Environmental Monitoring (EM) to identify trends and establish corrective measures.Work with other teams to improve processes and systems, growing the Sterility Assurance Level (SAL).Review and implement surveillance plans for aseptic techniques, ensuring any gaps are addressed.Support engineering projects, particularly in the design phase, to ensure sterility assurance.Prepare and revise risk assessments in compliance with Annex 1.Minimum Requirements/Qualifications
Education:
Bachelor’s Degree in Life Sciences, Chemical/Biochemical Engineering, or a related Pharma Scientific Area with equivalent experience consideredExperience:
1 to 2 years of experience in a Quality department within a sterile production manufacturing siteProficiencies:
Knowledge of cGMP environmentsTechnical expertise in microbiology, Endotoxin, Bioburden, Sterility, and associated testing protocolsCompliance with local, state, and federal regulations (, NMPA, HSA, FDA)Effective communication skills across all organizational levelsAbility to work cross-functionally with Quality Control, Operations, and Biologics teamsParticipation in Health Agency/internal auditsTechnical skills:
Strong background in sterility assurance, aseptic techniques, manufacturing of sterile injectables and Contamination Control Strategy (CCS).