Lowongan Senior Specialist, QA - (R52070) di PT Capsugel Indonesia

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.

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.

As a QA Specialist you will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.

Key responsibilities:

• Lead in complex deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.

• A competent Reviewer and Approver of SOPs, protocols, reports or records.

• Member of cross functional site team(s) on projects / issues

• Coordinate between departments for multiple parallel activities

• Superior ability to troubleshoot; able to identify process pathway and work to develop improvement in strategy site team(s) on projects/ issues.

• Understanding of advanced topics pertaining to cGMP

• Develop skills as an internal GxP auditor, as required.

• Participate in Regulatory Inspections or Customer Audits as required.

• Identify process pathway and work to develop improvement 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 trend in the appropriate area in which the individual operates

• Any other tasks as and when assigned by supervisor.

Key requirements:

• Bachelor's degree in engineering/Science Degree or higher from recognized institution with 5 to 10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry.

• Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)

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.