QA Production Associate

3 weeks ago

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

Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform 12-hour shift (full night shift preferably).

Responsibilities

  • Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations
  • Participate in on the floor triage and support root cause investigations for major investigation if applicable
  • Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders
  • Support in regulatory inspections, and interact directly with regulatory inspectors
  • Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation
  • Escalate any significant event to Quality management in a timely manner

About You:

  • Bachelor's Degree in Science and 2 years of directly related experience OR High school diploma/GED in Science and 4-6 years of directly related experience
  • 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems.
  • Direct experience with bulk manufacturing of biopharmaceuticals preferred.
  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
  • Fluency in written and spoken English
  • Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern
Tell employers what skills you have

Supplier Quality
Quality Management
Technical Writing
Quality Assurance
Investigation
Manufacturing Operations
Compliance
Change Control
Manufacturing
Biopharmaceuticals

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