Quality Assurance Expert

2 weeks ago

Singapore beBeeCompliance Full time $80,000 - $120,000

Job Description:

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This role focuses on ensuring the highest standards of quality in a manufacturing environment. The successful candidate will have experience in batch record review, SOP revisions, and quality assurance oversight.

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Responsibilities:

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The Quality Operations Specialist will be responsible for:

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  • Revising and reviewing Standard Operating Procedures (SOPs) to ensure compliance and quality standards">
  • Reviewing executed Manufacturing Batch Records (MBR) / Equipment Batch Records (EBR) for completeness and accuracy">
  • Providing quality oversight and support to the manufacturing team, addressing any quality-related queries, concerns, or issues">
  • Participating in GMP (Good Manufacturing Practices) and GEMBA walks to ensure adherence to quality standards on the shop floor">
  • Providing quality support for Change Control processes, ensuring compliance with quality standards">
  • Managing and reviewing deviations, ensuring thorough investigations and timely closure">
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Requirements:

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The ideal candidate should have:

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  • A minimum of 2 years of experience in the pharmaceutical or biopharma industry (preferred), including experience in batch record review, SOP revisions, or quality assurance oversight">
  • Experience in GMP and operational oversight activities (e.g., GEMBA, GMP walks) is advantageous">
  • Experiene in Manufacturing Batch Records (MBR) / Equipment Batch Records (EBR)">
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Interested candidates are encouraged to submit their updated resumes for consideration.

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Required Skills and Qualifications:

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Lifesciences, cGMP Manufacturing, cGMP, Quality Control, Quality Assurance, Healthcare, GMP environment, cGMP Practices, GMP, Compliance, Change Control, Manufacturing

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Keyword: Candidate must have Compliance skills

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