QA Associate

at  BIOSYNGEN PTE LTD

QA ASSOCIATE

The QA Associate coordinates and conducts activities of the Quality Assurance Department to provide overall site function support included manufacturing floor support and ensure quality oversight throughout the facility’s operational hours for all ongoing GMP activities.

EXPERIENCE REQUIREMENTS

• Bachelor’s Degree.
• More than 3 years of experience in a Bio-Life science environment. GMP experience is advantageous.
• Working understanding of GLP-Lab/GMP Operations, QC, QA, Process Development, Supply Chain, and related functions such as Facilities/Engineering.
• Strong knowledge and understanding of Quality System functions, manufacturing/packaging processes, validation, engineering drawings, and basic statistical processes.
• Involvement in setting up a New Site and/or Project Management is an added advantage.
• Motivated self-starter, capable of influencing change in an ambiguous environment.
• Matured, able to work in fast phase and high-pressure environment.
• Good technical writing, communication, and presentation skills.
• Able to speak, read, and write Chinese.

• Participate in setting up and maintaining of Quality Assurance documentation.
• Responsible for briefing relevant Facilities/Engineering/Supply Chain and Quality Control personnel on cGMP and hygiene procedures required for entering the dispensing and production areas.
• Writing, reviewing and/or approving QA-controlled documentation (such as SOPs, batch records, and work instructions).
• Writing and issuing SOPs for site qualification and validation projects as needed, example technology transfer project.
• Preparing manufacturing final batch release documentation, reviewing and approving related final batch records and ensure timely closure of manufactured batches.
• Reviewing and approving routine facilities/utilities/equipment, computerized systems scheduled maintenance/calibration records to ensure cGMP compliance.
• Reviewing and approving environmental monitoring data and analyse the trending for any potential impact.
• Reviewing and approving validation deliverables related to facilities/utilities/equipment, computerized systems (automation), and laboratory equipment/systems to ensure compliance with company procedures, regulatory requirements, cGMP expectations, and project schedules.
• Participate and provide QA input for Risk Assessment to ensure the compliance to cGMP requirements.
• Participate and provide QA input for User Requirements Specification to ensure compliance to cGMP requirements.
• Participate and provide QA input for Facilities/Engineering Qualifications, Processes Validation, and Computerized System Validations to comply with cGMP requirements.Participate and support in deviation root-cause investigation, reviewing/approving deviation closure with solid CAPA implementation.