Singapore Job Openings
LONZA BIOSCIENCE SINGAPORE PTE. LTD.
Specialist 2 QA
Singapore
FULL TIME
November 4, 2024
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:
- Support daily Quality Assurance activities in accordance with approved SOPs / Policies for a large scale, multi-product, GMP biotech manufacturing facility.
- Planning for future activities and coordinate with other departments to complete the workflow.
- Develop skills to be Qualified Trainer in area of expertise.
- Develop in depth awareness of entire process; identifying operational factors which influence the process.
- Participates in Regulatory and Customer Audits.
- Support in performing gap assessments between group documents and or regulatory guidelines
- Participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
- Ensure real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
- Develops good working relationships with internal & external customers.
- A competent Reviewer and Approver of SOPs, protocols, reports or records.
- Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
- Any other tasks as and when assigned by supervisor.
- Bachelor's degree with 2-5 years’ experience in Quality Assurance in the Biopharmaceutical industry.
- Relevant QA Operations background with experience in leading small team for projects.
- Experience in deviation investigation, change control and CAPA activities.
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
- Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and timelines.
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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