Specialist 1 Quality Assurance- Cell Therapy

Full Time, onsite
Lonza
Tuas, Singapore

Salary undisclosed

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Today, Lonza is a global leader in life sciences 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 Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facilityDuties and Responsibilities:

Display a good level of problem solving ability by analyzing and interpreting data and puts forward new ideas based on scientific knowledge or field experience
Detect non-compliance with cGxP and cGDP requirements and provide guidance on GDP corrections
Generally provide basic compliance support to staff in all departments
Demonstrate appropriate interpersonal skills that encourage collaboration of individuals or teams to meet objectives
Review executed batch records and logbooks and ensure that deviations are raised.
Compile lot genealogy.
Compile lot disposition packages and drive lot disposition activities to ensure timely release of product.
Provide oversight to product status, including preparation of documents for shipping activities.
Provide oversight to quality tag out system.
Participate actively and approve deviation investigations, utilizing Root Cause Analysis tools to enable effective and timely closure of deviation investigations.
Provide oversight to ensure correct implementation of CAPA based on deviation raised and ensure timely closure of CAPA.
Escalate process events on the floor based on knowledge of defined SOPs & policies
Support changeover activities.
Provide Quality oversight for Operations document changes (e.g. MBRs, SOPs, Forms, Logbook, etc.).
Together with Senior QA specialist provide Quality Change Request oversight for process and Operation change.
Participate in walk down/ QA On Shopfloor and provide feedback.
Participate in Regulatory and Customer Audits.
Lead/ participate and coordinate projects.
Develop good working relationships with internal & external customers.
Perform material release, joint inspection to identify material defect and review vendor’s investigation report as required
Any other tasks as and when assigned by supervisor

Requirement:

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 ICHQ7)
Knowledge and experience of the practical and theoretical requirement of quality managementsystem in GMP facility
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.R63696

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