Quality Operations Associate

6 days ago


Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Roles & Responsibilities

Quality Operations Associate must assist site management to oversee 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:

  • 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

Duration : 06 months. Option to extend/convert subject to performance review.


Based in Tuas.



Tell employers what skills you have

Warehousing
FDA
Technical Operations
Quality Management
Change Management
Quality System
Site Management
Manufacturing Processes
Supply Chain
GMP
Administration
Team Player
Laboratory
Manufacturing
Audit

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