Quality Operations Specialist (pharma/biotech)

Singapore, Singapore

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Responsibilities:

Main responsibilities include overseeing batch record review and incoming material quality audit
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
Ensure site and global quality compliance
All other responsibilities of QA Ops related.
Any other task as assigned by Supervisor/Manager
Based in Tuas

About You:

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
Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
Relevant QA Operations background from pharma or biotech environment is preferred
Familiar with Health Authorities standards (e.g., FDA CFR and EU)
Must be team player, meticulous, strong analytical and organizational skills

Salary: $3,000.00 - $5,000.00 per month Experience:

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