Quality System Specialist

4 weeks ago

Singapur, Singapore Antaes Consulting SA Full time

Job Responsibilities:

  • Contribute to Life Science projects for Antaes Asia clients
  • Act as a key member of the Quality Systems team, providing quality oversight for validation activities, including the critical area of Data Integrity
  • Ensure compliance with regulatory standards and internal policies for all validation processes
  • Collaborate with Subject Matter Experts (SMEs) and the validation team to conduct gap analysis and risk assessments prior to qualification activities.
  • Identify potential gaps and risks, proposing effective mitigation strategies to ensure compliance and operational excellence.
  • Participate in investigations related to validation discrepancies and assist in reviewing and approving discrepancy reports.
  • Support the closure of Corrective and Preventive Actions (CAPA) associated with validation issues, ensuring timely and effective resolution.
  • Review and approve a wide range of validation documentation, including but not limited to protocols and reports, ensuring accuracy, compliance, and alignment with quality standards.
  • Provide critical feedback and ensure that validation documents meet regulatory and company requirements.
  • Serve as a resource for validation-related queries and issues, providing guidance to teams and ensuring swift resolution of problems.
  • Review and approve Standard Operating Procedures (SOPs), FORMs, Manufacturing Batch Records, and other relevant procedural documents to ensure they align with current good manufacturing practices (cGMP) and company policies.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

  • 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
  • Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
  • Excellent communication skills, both written and verbal, in English
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