Quality Assurance Specialist

2 weeks ago

Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time $60,000 - $120,000 per year

Responsibilities:

  • Ensure adherence to the Change Control management systems and processes.
  • Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed.
  • Evaluate Change Control requests for process, validation, regulatory and product impact.
  • Coordinate the review and approval process of change requests to ensure timely execution of changes.
  • Ensure all site changes are managed appropriately to meet the expectation of the global change control board (if applicable) and meets site project timelines.
  • Participate in cross functional and cross site change management forums.
  • Collaborate with departments to ensure change control activities are executed efficiently and effectively, to provide supporting assistance to stakeholders in the process.
  • Ensure completion of required change control actions prior to lifting lot disposition restrictions.
  • Assist in the development and delivery of training materials and qualifications for Change Control processes and Change Management applications.
  • Perform Change Records review in support of Annual Product Review activities.
  • Ensure maintenance and continuous improvement of change control and processes.
  • Support regulatory inspections and provide audit support with team, which may include presentations and facility, utility, equipment documentation review.
  • Compliance with cGMP and site safety & security regulations at all times
  • Any other duties as assigned by supervisor or manager.

About You:

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
  • 3+ years of experience in a GMP-regulated biopharmaceutical or pharmaceutical
  • manufacturing environment.

Job Type: Contract

Contract length: 12 months

Pay: $4, $8,000.00 per month

Experience:

  • Change Control management systems: 3 years (Preferred)
  • biopharmaceutical or pharmaceutical: 3 years (Preferred)
  • qualifications for Change Control processes: 3 years (Preferred)

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