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Lonza

Global life sciences contract manufacturer

Quality Assurance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSingaporeNo salary listed

About the Job

Requirements

  • A degree or higher from a recognized institution is required.
  • Three to ten years of experience in Validation or a Quality unit in the biopharmaceutical industry is required.
  • Familiarity with regulatory requirements and local codes and standards, such as the FDA, EMEA, and ICH Q7, is required.
  • Good knowledge and practical and theoretical experience with a quality management system in a GMP facility are required.
  • Ability to operate independently while maintaining focus on safety, quality, and timelines is required.

Responsibilities

  • Support daily Quality Assurance activities in compliance with approved standard operating procedures, policies, and current Good x (cGxP) requirements.
  • Review and approve standard operating procedures, protocols, reports, and quality records.
  • Lead deviation investigations, change controls, corrective and preventive action plans, and troubleshooting activities.
  • Ensure data integrity and drive continuous quality improvement.
  • Support and lead regulatory inspections, customer audits, and audit responses.
  • Perform material release, qualification, and defect inspections, and review vendor investigation reports.
  • Lead projects, manage deliverables, and coordinate cross-functional activities.
  • Maintain stakeholder relationships and develop training and internal Good x practice auditing competencies.
  • Participate in facility walkdowns and perform other duties as assigned.

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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