Quality Assurance Specialist

4 weeks ago

Singapur, Singapore Antaes Consulting SA Full time

Job Responsibilities:

  • Contribute to Life Science projects for Antaes Asia clients.
  • Perform detailed reviews of raw materials, intermediate products, and finished products for compliance with quality specifications.
  • Manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.
  • Ensure that all batch records and associated documentation are reviewed and meet regulatory requirements before product release.
  • Provide on-site quality oversight during the manufacturing process, ensuring that all operations comply with Good Manufacturing Practices (GMP) and company quality standards.
  • Collaborate with manufacturing teams to address any quality-related issues that arise during production and ensure prompt resolution.
  • Conduct regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement.
  • Document findings from walk-throughs and collaborate with the relevant teams to implement corrective actions where necessary.
  • Review, revise, and approve Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up to date and compliant with current regulations and company policies.
  • Ensure that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients.

Job Requirements:

  • Bachelor’s degree in Biotechnology, Pharmaceutical or related field.
  • 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry.
  • Experience with product and raw material release processes and related documentation.
  • Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance.
  • Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks.
  • Proficient in reviewing and approving procedures such as SOPs, forms, and batch records.
  • Strong attention to detail and ability to work in a fast-paced, regulated environment.
  • Excellent communication and collaboration skills to work with cross-functional teams.
  • Good communication and problem-solving skills.
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