Quality Assurance Specialist

24 hours ago

Singapore SIGMA-ALDRICH PTE. LTD. Full time
Quality Assurance Specialist

At SIGMA-ALDRICH PTE. LTD., we are seeking a highly skilled Quality Assurance Specialist to join our team in Singapore. As a key member of our Quality Assurance team, you will play a critical role in ensuring the quality and integrity of our biologics safety testing business.

Key Responsibilities:
  • Perform batch record review and approval of GxP documents, including protocols, technical specifications, batch records, workbooks, SOPs, and other QMS documentation.
  • Conduct in-process or final audits and approval of manufacturing or testing documentation to ensure compliance with regulatory standards and approved TS, protocols, or SOPs.
  • Release certificates of analysis for GMP testing against TS and associated documentation.
  • Prepare QA statements within GLP final reports, specifying inspection dates and dates findings were reported to the Study Director and management.
  • Review and approve deviations, anomalous results, OOS, positive results, and CAPAs.
  • Assist in investigations from events, complaints, or data audits.
  • Conduct trend analysis for deviations and review/approve applicable CAPA records.
  • Assist self-inspections to ensure continuous improvement.
  • Perform and support client audits, regulatory inspections, internal audits, and supplier audits.
  • Comply with Health and Safety Executive regulations and undergo relevant training modules when required.
  • Perform duties according to the principles of Good Laboratory (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP).
Requirements:
  • Graduate degree in life sciences or higher related degree.
  • Minimum of 2-4 years of experience in a similar Quality Assurance role, with batch record review experience.
  • Desire and motivation to work in a Quality and regulated environment.
  • Awareness of Biologics regulatory environment and GMP manufacturing topics.
  • A proactive approach to all aspects of Quality.
  • Fluent in both written and spoken English.
  • Good communicator, dealing directly and effectively with operational teams and site QA and lab colleagues.
  • Strong analytical and problem-solving abilities.
  • Organized and logical in defining workload and delivering projects.
Core Competencies:
  • Technical and problem-solving skills.
  • Functional and technical knowledge and skills to do the job.
  • Ability to learn new skills and knowledge quickly.
  • Logical problem-solving with effective solutions.
  • Good decision-making.
  • Energy and drive.
  • Self-motivating, action-oriented, and full of energy for challenging tasks.
  • Pursues everything with energy, drive, and the need to finish, especially in the face of resistance and setbacks.
  • Can be counted on to achieve goals, constantly and consistently, pushes self and others for results.
  • Professional and interpersonal skills.
  • Relates well to all kinds of people in the organization, builds constructive and effective relationships using diplomacy and tact.
  • Seen as a team player, cooperative, easily gains support of peers, encourages collaboration.
Additional Local Needs:
  • Global mindset and willingness to engage in conference calls at out-of-office hours.

We are a company that values diversity, inclusion, and belonging. We believe that our differences are what drive excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at their own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.

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