Senior Sterilization Expert

4 days ago


Singapore beBeeSterility Full time $65,600 - $104,225
Quality Assurance Specialist in Sterility

The role of a Sterility Assurance Specialist is pivotal in ensuring the flawless production of injectable sterile pharmaceuticals. As part of our quality assurance team, you will be responsible for adhering to cGMP norms and regulatory procedures. Your expertise will be crucial in guaranteeing safety throughout the organization.

Key responsibilities include developing and maintaining Contamination Control Strategy (CCS) for the site, ensuring compliance with regulations. This involves coordinating maintenance activities to minimize environmental contamination and product risk. Additionally, you will collaborate with investigation teams to manage quality events impacting sterility and evaluate deviations and complaints.

Other key responsibilities include reviewing and approving major deviations and corrective/preventive actions related to sterility assurance. You will also contribute to SOP development and revision, evaluating necessary changes. Furthermore, you will analyze data from Environmental Monitoring (EM) to identify trends and establish corrective measures.

In this role, you will work closely with other teams to improve processes and systems, growing Sterility Assurance Level (SAL). You will also review and implement surveillance plans for aseptic techniques, addressing any gaps. Additionally, you will support engineering projects, particularly in design phase, ensuring sterility assurance.

Requirements/Qualifications:

Education: Bachelor's Degree in Life Sciences, Chemical/Biochemical Engineering, or a related field with equivalent experience considered.

Experience: 1-2 years of experience in a Quality department within a sterile production manufacturing site.

Proficiencies: Knowledge of cGMP environments, microbiology, Endotoxin, Bioburden, Sterility testing protocols, and compliance with regulations (e.g., NMPA, HSA, FDA). Effective communication skills and ability to work cross-functionally are essential.

Technical Skills: Strong background in sterility assurance, aseptic techniques, manufacturing of sterile injectables, and Contamination Control Strategy (CCS).



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