Quality Operations Associate
6 days ago
**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.
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
**12 months. Subject to extension/conversion based on performance.
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