Specialist 1, QA

Singapore, Tuas Singapore

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.

The QA Specialist will be responsible for the development and implementation of compliant quality systems for the site. Role will support the site with the implementation of upgrades to current Lonza global quality systems and the introduction to new global quality systems.
**Key responsibilities**:
Manage and maintain the Document Management Systems (DMS) and processes:

- Maintain the electronic system Documentum, including managing the associated work flows for new/ revised documents
- Manage the requests for, issuance and subsequent archival of log books used for documenting GMP activities
- Manage the requests for and subsequent issuance of Batch Records used in executing manufacturing steps necessary in performing a specific process
- Manage access rights for the system
- Manage Sysaids for the system

Manage and maintain the Training Systems (LMS) and processes:

- Maintain the SAP HR LMS Training system, including data input and administration functions of the LMS system
- Co-ordination of training delivery across the shifts of the site
- Ensuring training documentation is cGMP compliant and up to date
- Generating training performance metrics or other reports from the LMS
- Manage contractor and temporary employee files
- Interact with internal customers on training related matters
- Assist in developing of training materials in line with the requirements of the site training program
Any other tasks as and when assigned by supervisor.
**Key requirements**:

- Bachelor Degree with relevant work experience in Quality Assurance, validation from the Biopharmaceutical industry
- Experience in Computer system Validation (or highly IT savvy) will be an advantage
- Exposure to Quality Management Systems, Quality IT system including Trackwise, Document management and Training systems
- Understanding of cGMPs and compliance in a GMP manufacturing setting performing both supervised and unsupervised tasks
- Role will be responsible for daily task involving documentation control, tracking matrix, gap analysis and SOP revision
- Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
- Familiarity with Regulatory requirements and local Codes & Standards (e. g., FDA, EMEA, andlCHQ7)
- 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.

**Reference: R45485**:
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