Senior Compliance Officer

6 days ago

Singapore beBeeQualityAssurance Full time $90,000 - $120,000
Quality Assurance Specialist

We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance, with expertise in GMP, GDP, and internal standards.

Key Responsibilities:
  • Plan and lead supplier audits for contract manufacturers and material suppliers as part of supplier qualification and periodic performance evaluations.
  • Prepare and maintain quality agreements, documenting the defined roles and responsibilities of contract givers and contract acceptors in compliance with applicable GxP requirements.
  • Develop, review, and maintain QA-related SOPs and documentation, covering areas such as contract activities management, supplier qualification and performance review, and Annual Product Review (APR).
  • Maintain an organized and GDP-compliant documentation system, serving as a documentation controller to ensure traceability and regulatory readiness.
  • Own and maintain the approved supplier and material list, ensuring updates reflect current qualification status and compliance with regulatory requirements.
  • Participate in cross-functional risk assessments, contributing to the identification and mitigation of quality and compliance risks.
  • Plan and conduct self-inspections in accordance with GDP requirements to monitor internal compliance and drive continuous improvement.
  • Support product complaints investigation and management, collaborating with the CMC team to ensure timely resolution and proper documentation.
  • Coordinate with other departments on evaluation of deviation requests, ensuring risk and impact are properly assessed and documented.
Qualifications and Requirements:
  • Bachelor's degree in Pharmacy, Life Sciences or related field.
  • Minimum 3 years of QA experience in pharmaceuticals or other health products industry.
  • Good working knowledge of GMP, GDP or similar quality management system.
  • Experience working with contract manufacturers is an advantage.
  • Strong attention to detail and documentation accuracy.
  • Good communication and coordination skills, especially across cross-functional teams.
  • Ability to work independently and manage multiple tasks under stipulated timelines.
  • Flexibility to travel overseas for business-related assignments including supplier audits.
  • Excellent writing skill.
  • Detail oriented, organized and proactive.
  • Continuous Improvement mindset.
  • Proficiency in written and spoken English and Chinese (for bilingual documentation & correspondence).

About this Role:

This role involves extensive interactions with various departments and stakeholders, requiring strong interpersonal and communication skills. The selected candidate will be expected to work independently, managing multiple priorities and meeting deadlines while maintaining high-quality deliverables.

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