Senior Specialist 2, QA (Compliance)

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a Senior QA Specialist to support Quality Assurance activities and maintain compliance in a cGxP manufacturing facility. The ideal candidate will have a degree in Engineering or Science, along with 5-10 years of experience in the biopharmaceutical industry. Responsibilities include leading investigations, ensuring data integrity, and participating in audits. This role offers a significant opportunity to contribute to quality standards and make a positive impact on lives globally.

Qualifications

• 5 to 10 years of experience in Quality in the Biopharmaceutical industry.
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
• Good knowledge and experience of the practical and theoretical requirements of quality management system in GMP facility.

Responsibilities

• Support day-to-day Quality Assurance activities in accordance with approved SOPs.
• Lead in complex deviation investigations, change controls and CAPA proposals.
• Participate in Customer / Agency Audits and Inspections as required.
• Uphold data integrity principle in accordance to company policies.

Skills

Good interpersonal skills

Effective Communicator

Analytical Mind

Meticulous and Systematic

Team player

Education

Degree in Engineering/Science

Job description

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

As a Senior QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility in Quality Compliance (External).

Key Responsibilities

• Highly motivated individual and have superior skills in all areas relevant to the job.
• Member of cross-functional site team(s) on projects/ issues.
• Lead in complex deviation investigations, change controls and CAPA proposals.
• Superior ability to troubleshoot.
• A competent Reviewer and Approver of SOPs or records.
• Able to coordinate between departments for multiple parallel activities.
• Understanding of advanced topics pertaining to cGMP.
• Participate in Customer / Agency Audits and Inspections as required.
• Identify process pathways and work to develop improvements in strategy.
• Help/Transfer and quickly assimilate to leadership role in other process areas.
• Assume Supervisory responsibility in absence of supervisor
• Understands and articulates company business strategy. Maintains a broad view of the business, recognize changes and trends in the appropriate area in which the individual operates.
• Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate. identify and improve data integrity process.
• Perform material release and qualification, joint inspection to identify material defect and review vendor’s investigation report as required.
• Coordinates to deliver Supplier Quality Agreements in a timely manner
• Owns documents of the assigned Quality Process when applicable
• Develop skills to be Qualified Trainer in area of expertise
• Subject Matter Expert in one or more area of expertise
• Any other tasks as and when assigned by supervisor.

Key Requirements

• Degree in Engineering/Science or higher from recognized institution with 5 to 10 years’ experience in Quality in the Biopharmaceutical industry
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
• Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
• Good interpersonal skills
• Effective Communicator (oral and written)
• Exhibit good quality decision making traits
• Meticulous and Systematic and Analytical Mind
• Team player who can operate independently, with strong focus on safety, quality and timelines

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.