Specialist 3, Validation and Technical Compliance, QA
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Did you know that we are the 1st biologics contract manufacturer in ? 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.
Key Responsibilities
Provides QA oversight to QC/DS laboratory services
Review and approval of protocols and reports.
Provide QA oversight in deviation investigation, discrepancy reports and CAPA implementation.
Participate actively, utilizing Root Cause Analysis tools to enable effective and timely closure of records.
Provides Quality Change Request oversight for Lab service changes.
Liaise with cross functions, communicating information and updates in timely manner
Develops good working relationships with internal & external customers.
Participate in cross-functional walk down and provide feedback
Lead and coordinate projects and manage the deliverables effectively.
Develop skills to be Qualified Trainer in area of expertise
Develop skills to front auditors as SME/ supporting QA oversight
Key Requirements:
Bachelor's degree with significant years’ experience in Quality Assurance in the Biopharmaceutical industry.
Familiarity with Regulatory requirements and local Codes & Standards (eg. FDA, EMA and ICH Quality Guidelines)
Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
Able to operate independently with minimum supervision for routine work within established policies and procedures and receives detailed instructions on new projects and assignments.
Meticulous and Systematic.
Team player, 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.
