Job Description

Quality Operations Specialists must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches. Responsibilities: \xe2\x97\x8f Main responsibilities include overseeing batch record review and incoming material quality audit \xe2\x97\x8f Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities \xe2\x97\x8f 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 \xe2\x97\x8f Release incoming material, process, and product batches \xe2\x97\x8f Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product \xe2\x97\x8f Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies \xe2\x97\x8f Ensure site and global quality compliance \xe2\x97\x8f All other responsibilities of QA Ops related. \xe2\x97\x8f Any other task as assigned by Supervisor/Manager \xe2\x97\x8f Based in Tuas About You: \xe2\x97\x8f Bachelor Degree with at least 1-2 years\' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Fresh graduates with GMP internship experience are welcome to apply \xe2\x97\x8f Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility \xe2\x97\x8f Relevant QA Operations background from pharma or biotech environment is preferred \xe2\x97\x8f Familiar with Health Authorities standards (e.g., FDA CFR and EU) \xe2\x97\x8f Must be team player, meticulous, strong analytical and organizational skills Job Type: Contract
Contract length: 12 months Salary: $3,500.00 - $6,500.00 per month Experience:

• active pharmaceutical ingredient (API): 1 year (Preferred)
• Manufacturing/Operation: 1 year (Preferred)