Electronic Batch Records Quality Specialist

MANTU GROUP SA

Singapore

On-site

SGD 65,000 - 110,000

Full time

14 days+
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Job summary

Amaris Consulting seeks a QA Specialist to join its Life Sciences team in Singapore. You will review and approve electronic batch records, ensure GMP compliance, and uphold data integrity across manufacturing documentation.

Collaborating with Production, Quality Assurance and cross-functional teams, you will drive continuous improvement, maintain records, and support deviations and CAPA when required. Fluency in English is essential, with additional languages a plus.

Qualifications

  • Experience with electronic batch records or electronic document management systems.
  • Knowledge of GMP, data integrity, and regulatory requirements in pharma.
  • Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, or Life Sciences.
  • Fluent English; another language is a plus.
  • Strong attention to detail and stakeholder management.

Responsibilities

  • Review and approve electronic batch records per GMP and procedures.
  • Identify discrepancies and data integrity issues in batch records.
  • Collaborate with Production, QA, and other teams to resolve issues.
  • Support timely review and release of manufacturing docs.
  • Conduct internal reviews or audits of electronic batch records.
  • Support deviation investigations and CAPA follow-ups.
  • Provide guidance on good documentation practices.
  • Contribute to continuous quality process improvements.
  • Maintain electronic record management systems and data integrity.

Skills

Electronic batch records
GMP knowledge
Data integrity
Documentation practices
Regulatory requirements

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Life Sciences

Tools

Electronic Document Management Systems

Job description

Amaris Consulting seeks a QA Specialist to join its Life Sciences team in Singapore. You will review and approve electronic batch records, ensure GMP compliance, and uphold data integrity across manufacturing documentation.

Collaborating with Production, Quality Assurance and cross-functional teams, you will drive continuous improvement, maintain records, and support deviations and CAPA when required. Fluency in English is essential, with additional languages a plus.

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