ANTER CONSULTING PTE. LTD. is seeking a Senior QA Specialist to enhance their Site Quality team, focusing on Quality Management Systems and ensuring compliance with regulatory standards in biologics manufacturing. The ideal candidate should have significant experience in Quality Assurance, particularly in biopharmaceutical environments, and possess strong skills in document control and compliance activities
Job Summary
We are seeking an experienced Senior QA Specialist to join the Site Quality team supporting biologics manufacturing operations.
This role will focus on Quality Management Systems, document control, archival strategy, and continuous improvement initiatives, ensuring compliance with cGMP standards and regulatory requirements across site activities.
The position involves collaboration with Manufacturing, Engineering, Validation, and QC teams to align quality processes with operational needs and support internal and external audits and regulatory inspections.
Matching Summary
Match Score: 85
ANTER CONSULTING PTE. LTD. is seeking a Senior QA Specialist to enhance their Site Quality team, focusing on Quality Management Systems and ensuring compliance with regulatory standards in biologics manufacturing. The ideal candidate should have significant experience in Quality Assurance, particularly in biopharmaceutical environments, and possess strong skills in document control and compliance activities.
Salary
SGD 6,000 - 8,500 / Monthly
Skills & Requirements
Must-have
Quality Management Systems (QMS)
document control activities
cGMP compliance
SOP authoring and review
change control processes
archival/document management systems
data integrity principles (ALCOA+)
Nice-to-have
electronic document management systems experience
stakeholder management skills
cross-functional collaboration
inspection readiness support
mentorship of junior QA staff
Key Requirements
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related discipline
Minimum 5 years of Quality Assurance experience in biopharmaceutical/biologics manufacturing
Good understanding of cGMP regulations (FDA, EMA, PIC/S)
Experience supporting regulatory inspections and audit readiness