Job Description:
- 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
