QA Operation

2 weeks ago

Tuas West Region, Singapore NUSANTARA PRIME CONSULTING PTE LTD (Nusaprime) Full time $70,000 - $120,000 per year

Main Responsibilities:

Responsible for overseeing manufacturing, testing and validation activities, ensuring compliance with internal procedures and regulatory requirements.

Responsibilities:

  • Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
  • Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
  • Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained
  • Accountable for QA Review of all Qualification and Validation protocols and reports, including computer system validation.
  • Ensures that the data integrity of all documentation and electronic data complies to all application regulations and SOP requirements
  • Participate in site operational readiness programs, including self-inspection and data integrity surveillance for GMP and client audits.
  • Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
  • Carry out additional tasks as assigned by leadership.

About You:

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
  • At least 3-5 years of relevant QA experience in Biopharma or Pharmaceuticals
  • Familiar with FDA, EMEA, and PICS GMP requirements.
  • Knowledgeable in biological product manufacturing and related quality control requirements.
  • Experience in biopharma commercial supply is preferred.
  • Experience with a new site start-up is preferred.
  • Proficient in English listening, speaking, reading, and writing.
  • Skilled in Microsoft Word, Excel, PowerPoint, etc.
  • Strong learning ability.
  • Excellent cross-functional communication and collaboration skills.
  • Strong logical thinking and conflict management abilities.
  • Demonstrates strong ownership.

Contract Period: 12 months, convert to perm employee subject to performance during contract period.

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