Scientific Expert for Sterile Injectables

1 week ago

Singapore beBeeQuality Full time $90,000 - $120,000
Job Title: Laboratory Quality Assurance Specialist

Sterile Injectables - A Key Role in Pharmaceutical Product Quality

  • This role requires a qualified professional with 10-15 years of experience in Quality Assurance (Laboratory).

Key Responsibilities: Review and verify analytical data from chemical and microbiological analysis, ensuring data integrity and compliance with cGMP and regulatory standards.

Primary Responsibilities: Approve Certificates of Analysis (CoA) for final product release, conduct and review investigations related to laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) results.

Requirements: Identify root causes and recommend corrective and preventive actions (CAPAs) to ensure the quality and safety of products.

Accountabilities: Collaborate with microbiology and analytical teams to implement corrective measures based on trend analysis to maintain a sterile manufacturing environment.

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