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