About this role
The Lead QA Audit Specialist supports audit activities and regulatory inspections for a multi-product cGxP contract manufacturing facility. Responsibilities include leading audit walk-down preparations, managing inspection responses, and conducting complex deviation investigations.
Candidates must hold a bachelor's degree and possess proven experience in QA operations within a GMP-regulated biopharmaceutical environment. Proficiency in regulatory guidelines such as FDA, EMA, and ICH is required.
What they're looking for
GxP AuditingQuality AssuranceGMP ComplianceRegulatory InspectionsDeviation InvestigationsQuality Management SystemsFDA GuidelinesEMA Guidelines
Frequently asked questions
What does a Lead Specialist, QA (CGT) at Lonza do?
The Lead QA Audit Specialist supports audit activities and regulatory inspections for a multi-product cGxP contract manufacturing facility. Responsibilities include leading audit walk-down preparations, managing inspection responses, and conducting complex deviation investigations. Candidates must h…
What skills does this Lead Specialist, QA (CGT) role need?
Key skills for this role include GxP Auditing, Quality Assurance, GMP Compliance, Regulatory Inspections, Deviation Investigations, Quality Management Systems.
How much does a Lead Specialist, QA (CGT) at Lonza pay?
The employer did not list a salary for this role. Most similar Singapore roles publish their band on the job page.
Is this Lead Specialist, QA (CGT) role remote, hybrid, or on-site?
This role is on-site, based in Singapore.
How do I apply for this Lead Specialist, QA (CGT) role?
You can apply directly on Lonza's careers page. ApplyLah can tailor your résumé and cover letter to this exact role in seconds first.