Quality Assurance Specialist

2 days ago

Singapore beBeeQualityAssurance Full time $80,000 - $120,000
Job Title: Quality Assurance Specialist

We are seeking a highly motivated and experienced Quality Assurance Specialist to join our team. As a key member of the Quality Systems team, you will be responsible for providing quality oversight for validation activities, ensuring compliance with regulatory standards and internal policies.

Key Responsibilities:

  • Contribute to Life Science projects for clients
  • Provide quality oversight for validation activities
  • Ensure compliance with regulatory standards and internal policies
  • Collaborate with Subject Matter Experts (SMEs) and the validation team
  • Identify potential gaps and risks, proposing effective mitigation strategies
  • Participate in investigations related to validation discrepancies
  • Support the closure of Corrective and Preventive Actions (CAPA)
  • Review and approve a wide range of validation documentation
  • Provide critical feedback and ensure that validation documents meet regulatory and company requirements

Required Skills and Qualifications:

  • Bachelor's Degree in Biomedical Engineering, Biotechnology, Science or equivalent
  • 2-4 years of experience in a Quality Systems role within the pharmaceutical or biotechnology industry
  • Experience with validation processes and quality oversight, including data integrity
  • Strong understanding of cGMP regulations and validation principles
  • Experience with risk assessment, gap analysis, and CAPA processes
  • Problem-solving ability with a focus on proactive solutions and process improvement

Benefits:

  • Excellent communication skills, both written and verbal, in English
  • Highly motivated and able to work independently as well as in a team
  • Good organizational and oral and written communication skills

About Us:

We are a leading provider of Life Science services and are committed to excellence in all aspects of our business.

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