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Urgent! Quality Assurance Specialist (Pharma/Biotech) Job Opening In Singapore, Singapore – Now Hiring NUSAntara Prime Consulting Pte. Ltd.

Quality Assurance Specialist (Pharma/Biotech)



Job description

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.

Duration: 12-months contract role

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Required Skill Profession

Pharmacology, Quality Management & Operations



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