QA Specialist

5 days ago

Singapore ANTER CONSULTING PTE. LTD. Full time $90,000 - $120,000 per year

About the Role

We are hiring a QA Specialist for a leading pharmaceutical biologics client. This role offers an exciting opportunity to contribute to the assurance of quality standards in biologics manufacturing. The ideal candidate will bring 3+ years of experience in pharmaceutical quality assurance, with a strong emphasis on GMP compliance, batch record review, and regulatory readiness.

Key Responsibilities

  • Batch Record Review (BMRs): Review and approve batch records, ensuring that all documentation is complete and accurate. Handle deviations and discrepancies, ensuring they are properly documented, investigated, and resolved.
  • Deviation Management: Manage and investigate deviations, ensuring corrective and preventive actions (CAPA) are implemented to resolve quality issues.
  • Change Control: Support and manage change control processes to ensure all changes are evaluated, documented, and approved in compliance with GMP requirements.
  • Quality Systems & Compliance: Oversee quality systems activities such as cleaning validation, documentation reviews, and ensuring ongoing audit readiness.
  • Regulatory Inspections: Support preparations for regulatory inspections (FDA, EMA, NPRA, etc.), ensuring all documentation and processes are in compliance with regulatory requirements.
  • Data Integrity: Apply data integrity principles (ALCOA/ALCOA+) to maintain the reliability, completeness, and accuracy of all data within QA processes.

Requirements

  • 3+ years of experience in a QA role within the pharmaceutical biologics industry, with hands-on experience in batch record review, deviation management, and CAPA processes.
  • Strong understanding of GMP guidelines, quality systems, and compliance activities.
  • Familiarity with regulatory inspections and experience in preparing for or supporting audits (FDA, EMA, NPRA, etc.).
  • Knowledge of data integrity principles (ALCOA/ALCOA+) and demonstrated ability to apply them in QA operations.
  • Excellent attention to detail with strong problem-solving skills and the ability to handle complex compliance challenges.

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