Product Quality Assurance Specialist

1 day ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time
Job Summary

Prestige Biopharma Limited seeks a Product Quality Assurance Specialist to join our team. As a key member of the quality assurance department, you will play a critical role in ensuring the effective implementation of our Quality Management System.

About the Role

The Product Quality Assurance Specialist will be responsible for implementing quality management systems in accordance with company policies, cGMP, and international regulations. You will review test protocols, reports, batch records, and analytical data to ensure product quality meets specified requirements.

Key responsibilities include:

  • Implementing quality management systems and ensuring compliance with relevant regulations
  • Reviewing test protocols, reports, batch records, and analytical data to ensure product quality meets specified requirements
  • Participating in product quality activities, including reviewing OOS investigations, deviations, CAPAs, and risk management
  • Drafting and reviewing quality technical agreements
  • Providing quality data and trends to management as required
  • Performing internal audits to ensure effective implementation of quality management systems
  • Conducting audits at CMOs to ensure compliance with relevant guidelines, regulations, and agreements
  • Providing training and guidance on quality assurance procedures, regulations, and best practices
Requirements

To be successful in this role, you will need:

  • A degree in engineering (biomedical) or science (biology, chemistry, bio-engineering)
  • Minimum 2-3 years of experience in pharmaceutical quality assurance, with a focus on product quality management and compliance
  • Experience in bioprocessing technology (upstream and downstream operations)
Preferred Skills

We are looking for candidates with:

  • Strong analytical and problem-solving skills
  • Good computer skills, with the ability to adapt to technology efficiently
  • Results-oriented, multi-tasking, and quick learning abilities
  • Good knowledge and understanding of cGMP, FDA regulations, ICH guidelines, and other relevant regulatory guidelines and quality standards
  • Excellent oral and written communication skills
  • A proven track record of conducting audits, investigations, and implementing corrective actions
Salary Information

The salary for this position is approximately $85,000 per year, based on industry standards and market conditions.



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