QA Operations Specialist: Drive Batch Release & Quality

Sanofi Aventis Singapore Pte. Ltd

Singapore

On-site

SGD 70,000 - 110,000

Full time

10 days ago
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Job summary

Sanofi Singapore Pte. Ltd. is seeking a Quality Assurance (QA) Operations Specialist to partner with site GMP operations and the validation team to ensure quality, safety, reliability and compliance across batch records, release and CAPA processes.

You will assist in daily operations for batch review, batch disposition/release, deviations and CAPA-driven improvements. You will coordinate qualification and validation documentation, ensure investigations are scientifically justified, and support

Qualifications

  • Engineering or science degree with 3-5 years in quality operations within the pharmaceutical industry.
  • Experience in batch release, deviation handling and investigations preferred.
  • Strong written and verbal communication; ability to work cross-functionally.

Responsibilities

  • Review batch records and associated documentation, oversee batch review/approval.
  • Oversee batch release to meet regulatory and company standards (GMP).
  • Conduct and lead root cause investigations for deviations and laboratory findings.
  • Monitor CAPA effectiveness and drive timely closure.
  • Participate in audits and regulatory inspections; support internal QA activities.
  • Support continuous improvement initiatives to enhance batch release efficiency.

Skills

Batch release
Deviations handling
Investigations
CAPA
Cross-functional collaboration

Education

Engineering/Science degree

Job description

Sanofi Singapore Pte. Ltd. is seeking a Quality Assurance (QA) Operations Specialist to partner with site GMP operations and the validation team to ensure quality, safety, reliability and compliance across batch records, release and CAPA processes.

You will assist in daily operations for batch review, batch disposition/release, deviations and CAPA-driven improvements. You will coordinate qualification and validation documentation, ensure investigations are scientifically justified, and support

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