*URGENT* Quality Operations Specialist (West, Bio-Pharma MNC, Office Hours, $6K) - HWX
RECRUIT EXPRESS PTE LTD
Primary goals, objectives of this position
• Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. Incumbent is required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product.
Major responsibilities
• Ensure that products manufactured at the facility meet approved company policies, processes and procedures.
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by management
• Any other tasks as and when assigned by the Supplier Quality Supervisor
Requirements:
- Degree in Chemical Engineering and above
- Possess 2-3 years prior working experience in Quality Operations / Assurance functions preferrably in bio-pharma field
- Able to start work immediately or within short notice
Subject: QO Specialist
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registration No.: 99C4599
