QA Expert

Lonza Group Ltd.; Singapore; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a QA Expert to enhance Quality Assurance activities in a dynamic, multi-product cGxP contract manufacturing facility. This role involves monitoring daily operations, participating in regulatory inspections, and ensuring compliance with industry standards. The ideal candidate will have a strong background in the pharmaceutical manufacturing sector and a keen understanding of quality management systems. Join a forward-thinking organization that values creativity and problem-solving, and contribute to meaningful advancements in life sciences that positively impact millions of lives globally.

Qualifications

• Experience in Pharmaceutical Manufacturing or Quality Assurance.
• Familiarity with regulatory requirements like FDA and EMEA.

Responsibilities

• Monitor daily Quality Assurance activities in a cGxP facility.
• Participate in Regulatory Inspections and Customer Audits.
• Assume supervisory responsibilities in the absence of a supervisor.

Skills

Quality Assurance

Troubleshooting

Regulatory Compliance

Quality Management Systems

Team Collaboration

Education

Degree in Science or Related Field

Job description

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

The QA Expert will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility in one of these areas: Quality Systems, QA Validation and Technical Compliance, Quality Compliance (Audit / External) or Quality Operations (LBT / LBSS).

Duties and Responsibilities:

• Monitor day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility.
• Highly motivated individual with superior skills in all areas relevant to the job.
• A competent Reviewer and Approver of SOPs, protocols, reports, or records.
• Member of cross-functional site team(s) on projects/issues.
• Superior ability to troubleshoot; able to identify process pathways and work to develop improvements in strategy.
• Understanding of advanced topics pertaining to cGMP.
• Participate in Regulatory Inspections or Customer Audits 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.
• Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trends in the appropriate area in which the individual operates.
• Any other tasks as and when assigned by supervisor.

Requirements:

• Degree in science or related field.
• Relevant work experience in Pharmaceutical Manufacturing industry or Validation/Quality unit in the Biopharmaceutical industry.
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICH Q7).
• Knowledge and experience of the practical and theoretical requirements of quality management systems in GMP facilities.
• Team player who can operate independently, with a 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.