Quality Assurance Specialist

1 week ago

Singapore beBeeAssurance Full time $90,000 - $120,000
Job Description

This is an outstanding opportunity to contribute to the production of injectable sterile pharmaceuticals. As a QA Sterility Assurance Specialist, you will be responsible for ensuring the flawless execution of processes and procedures, adhering to cGMP norms and regulatory requirements.

Responsibilities include:

  • Guaranteeing safety remains our top priority throughout the organization.
  • Developing and maintaining the Contamination Control Strategy (CCS) for the site, ensuring compliance with regulations.
  • Coordinating maintenance activities within the sterility assurance department to minimize environmental contamination and product risk.
  • Collaborating with the investigation team to manage quality events impacting sterility and evaluate deviations and complaints.
  • Reviewing and approving major deviations and corrective/preventive actions related to sterility assurance.
  • Contributing to the development and revision of SOPs impacting sterility assurance and evaluating necessary changes.
  • Analyzing data from Environmental Monitoring (EM) to identify trends and establish corrective measures.
  • Working with other teams to improve processes and systems, growing the Sterility Assurance Level (SAL).
  • Reviewing and implementing surveillance plans for aseptic techniques, ensuring any gaps are addressed.
  • Supporting engineering projects, particularly in the design phase, to ensure sterility assurance.

Required Skills and Qualifications

To excel in this role, you should possess:

  • A Bachelor's Degree in Life Sciences, Chemical/Biochemical Engineering, or a related Pharma Scientific Area with equivalent experience considered.
  • 1-2 years of experience in a Quality department within a sterile production manufacturing site.
  • Strong technical expertise in microbiology, Endotoxin, Bioburden, Sterility, and associated testing protocols.
  • Compliance with local, state, and federal regulations.
  • Effective communication skills across all organizational levels.
  • Ability to work cross-functionally with Quality Control, Operations, and Biologics teams.

Benefits

Thermo Fisher Scientific offers a diverse and inclusive work environment with opportunities for growth and development.

Others

Please note that all employment decisions are based on merit, qualifications, and business needs.

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