Quality Assurance Specialist

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. #J-18808-Ljbffr