Quality Assurance Specialist

2 days ago

Singapur, Singapore Lonza Full time
Join Our Team as a Quality Assurance Specialist

Lonza is a global leader in life sciences, operating across three continents. Our success is built on the talent and dedication of our people, who work together to devise innovative solutions that help businesses improve people's lives.

We're proud to be the 1st biologics contract manufacturer in your region, offering exposure to upcoming biotech and established pharmaceutical companies. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms, and extensive experience.

Key Responsibilities
  • Provide QA oversight to QC/DS laboratory services, ensuring compliance with regulatory requirements and company policies.
  • Review and approve protocols and reports, ensuring accuracy and completeness.
  • Investigate deviations, discrepancies, and CAPAs, implementing corrective actions to prevent recurrence.
  • Participate in root cause analysis, enabling effective and timely closure of records.
  • Oversee quality change requests for laboratory service changes, ensuring compliance with regulatory requirements.
  • Liaise with cross-functional teams, communicating information and updates in a timely manner.
  • Develop good working relationships with internal and external customers, ensuring their needs are met.
  • Participate in cross-functional walk-downs, providing feedback and contributing to process improvements.
  • Lead and coordinate projects, managing deliverables effectively.
  • Develop skills to be a qualified trainer in your area of expertise.
  • Develop skills to front auditors as a subject matter expert, supporting QA oversight.
Key Requirements
  • Bachelor's degree with significant years of experience in Quality Assurance in the biopharmaceutical industry.
  • Familiarity with regulatory requirements and local codes and standards (e.g., FDA, EMA, and ICH Quality Guidelines).
  • Fair knowledge and experience of the practical and theoretical requirements of quality management systems in a GMP facility.
  • Able to operate independently with minimum supervision for routine work within established policies and procedures.
  • Meticulous and systematic.
  • Team player, with a strong focus on safety, quality, and timelines.

At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. We offer the satisfaction that comes with improving lives all around the world and making a meaningful difference.

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