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QA Specialist (Biopharmaceutical Manufacturing) #HDCA

Summary

QA Specialist ensures quality and regulatory compliance in a biopharmaceutical manufacturing environment by reviewing documentation, managing deviations, and supporting audit readiness.

Join a leading biopharmaceutical manufacturing environment where you'll play a key role in ensuring quality excellence and regulatory compliance. If you have a background in Science or Engineering and are passionate about quality systems, this is an excellent opportunity to contribute to impactful manufacturing operations.

Responsibilities

  • Support daily Quality Assurance activities within a cGxP manufacturing environment.
  • Review and approve SOPs, protocols, reports, and quality documentation.
  • Manage deviation investigations, change controls, and CAPA activities.
  • Participate in regulatory inspections, customer audits, and audit readiness initiatives.
  • Perform material release, qualification activities, and vendor quality assessments.
  • Drive continuous process improvements while maintaining data integrity standards.
  • Collaborate closely with cross-functional teams including QC, MSAT, and Supply Chain.
  • Lead assigned projects and ensure timely completion of deliverables.
  • Provide guidance and training within your area of expertise to support team development.

Requirements

  • Diploma or Degree in Science, Engineering, Biotechnology, Chemistry, Biomedical Science and above.
  • Experience in pharmaceutical or biopharmaceutical manufacturing or a quality-related environment is advantageous.
  • Familiarity with cGxP regulations, Quality Management Systems (QMS), deviations, change control, CAPA, and audit processes will be an advantage.
  • Strong analytical, problem-solving, and communication skills.
  • Meticulous, organised, and able to work independently while collaborating effectively with stakeholders.
  • Demonstrates accountability, adaptability, and a commitment to delivering quality outcomes.

Interested applicants, please send your updated resume to healthcaretemps@recruitexpress.com.sg

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd
EA License No. 99C4599

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