Specialist 2, Compliance

3 days ago

Tuas, Singapore Lonza Full time $60,000 - $80,000 per year

Singapore, Tuas SingaporeToday, 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.
The QA Specialist will be responsible to provide QA support for QC raw material lab, Supply Chain Operations, including purchasing, warehousing and shipping.
**Key Responsibilities**:
- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility.
- Take on role of QA Specialist in External QA
- A good understanding of cGxPs and compliance in a GxP manufacturing setting performing both supervised and unsupervised tasks.
- Receive mínimal supervision and able to perform independently on routine assignments.
- Provide support in regulatory inspections and customer audits as required.
- Revise, review and approve SOPs, protocols, reports or records.
- Make real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
- Demonstrate appropriate interpersonal skills which encourage collaboration of individuals or teams to meet objectives.
- Assist in deviation investigations, change controls and discrepancy reports.
- Develop skills as an internal GxP auditor, as required.
- Any other tasks as and when assigned by supervisor.
**Key requirements**:
- Bachelor's degree in science with 1-3 years of experience in Validation / Quality unit 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 with Good oral and written communication skills
- 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 achieve 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.
- Reference: R58343

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