Singapore Job Openings

Lonza

Specialist 3, QA Cell Therapy

Tuas

FULL TIME

October 23, 2024

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.
Responsibilities:

Possesses a deep understanding of the entire process, identifying operational factors that impact it.
Competent in reviewing and approving SOPs, protocols, reports, and records.
Skilled in troubleshooting, with the ability to assess all available information and select the most effective course of action.
Demonstrates leadership abilities by managing small projects and delivering results efficiently.
Builds and maintains strong working relationships with both internal and external stakeholders.
Plans and coordinates future activities in collaboration with other departments.
Works towards becoming a certified trainer in areas of expertise.
Takes on additional tasks as assigned by supervisors.
Reviews completed batch records and logbooks, ensuring proper deviation handling.
Compiles lot genealogy.
Escalates process events based on knowledge of established SOPs and policies.
Supports and coordinates changeover activities.
Provides quality oversight for document changes related to operations, including MBRs, SOPs, forms, and logbooks.
Oversees quality change requests for process and operational changes.
Detects non-compliance with c GMP and GDP standards and offers guidance on corrections.
Actively participates in shop floor walk-throughs and provides constructive feedback.
Participates in regulatory and customer audits.
Leads and coordinates projects while managing deliverables effectively.
Troubleshoots and assesses information to select the best course of action.
Acts as a change agent, reviewer, or approver for SOPs, protocols, reports, and records.
Participates or leads deviation investigations, change controls, and CAPA (Corrective and Preventive Action) plans.
Assists in investigations of deviations and change controls.
Provides guidance to junior QA Specialists (1 and 2) when needed.

Requirements:

Bachelor's degree with 5-7 years’ experience in Quality Assurance in the Biopharmaceutical industry.
Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
Pleasant personality
Good oral and written communication skills
Meticulous and Systematic
Team player, with strong focus on safety, quality and timelines
Able to operate independently with minimum supervision for routine work within established policies and procedures and receives detailed instructions on new projects and assignments.

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.

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