Senior Specialist Ii, QA Cell Therapy

Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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 Senior QA Specialist will support day-to -day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGxP contractmanufacturing facility in one of these areas: Quality Systems, QA Validation and Technical Compliance, Quality Compliance (Audit / External) or Quality Operations (LBT / LBSS).

Duties and Responsibilities:

- Monitor day-to -day Quality Assurance activities in accordance with approvedSOPs / Policies for a multi-product, cGxP contract manufacturing facility
- Highly motivated individual and have superior skills in all areas relevant to thejob
- A competent Reviewer and Approver of SOPs, protocols, reports or records
- Member of cross functional site team(s) on projects / issues
- Coordinate between departments for multiple parallel activities
- Superior ability to troubleshoot; able to identify process pathway and work todevelop improvement in strategy site team(s) on projects/ issues
- Understanding of advanced topics pertaining to cGMP
- Participate in Regulatory Inspections or Customer Audits as required.
- Identify process pathway and work to develop improvement in strategy
- Help/Transfer and quickly assimilate to leadership role in other process areas
- Assume Supervisory responsibility in absence of supervisor
- Understand and articulate company business strategy. Maintain a broad view of the business, recognize changes and trend in the appropriate area in whichthe individual operates
- Any other tasks as and when assigned by supervisor

Additional area:

- Review executed batch records and logbooks efficiently to ensure compliancewith cGMP per written procedures
- Compile lot genealogy
- Compile lot disposition packages and drive lot disposition activities to ensuretimely release of product.
- Provide oversight to product status, including preparation of documents forshipping activities.
- Provide oversight to quality tag out system
- Participate actively and approve deviation investigations, utilizing Root CauseAnalysis tools to enable effective and timely closure of deviation investigations.
- Provide oversight to ensure correct implementation of CAPA based ondeviation raised and ensure timely closure of CAPA.
- Timely escalation of quality events on the floor based on knowledge ofdefined SOPs and policies
- Support changeover activities and QA on Call
- Provide training to new members and manufacturing
- Provides Quality oversight for Operations document changes (e.g. MBRs,SOPs,Forms, Logbook, etc.).
- Provides Quality Change Request oversight for process and Operationchange
- Detect non-compliance with cGMP and GDocP requirements and provideguidance on GDocP corrections
- Revise, review and approve SOPs, protocols, reports or records

Requirement:

- Degree in science or related field
- Relevant work experience in Pharmaceutical Manufacturing industry or Validation / Quality unit in the Biopharmaceutical industry
- Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Knowledge and experience of the practical and theoretical requirement of quality managementsystem in GMP facility
- Team player who can operate independently, 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.

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