Technical Investigator

3 months ago

Singapur, Singapore Lonza Full time

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 ? 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 Technical Investigator is responsible for performing deviation investigation and documenting the process and the outcome of the investigation. This includes but not limited to root cause analysis, appropriate Corrective and Preventive Actions (CAPAs) definition and product impact Assessment.

Key responsibilities:

Perform detailed and thorough investigation for deviations, nonconformities and/ or abnormalities which occur on production floors utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, Failure Mode, Effect and Cause Analysis (FMECA). Perform recurrence analysis for deviation and ensure the information documented within the deviation is sufficient for assessment at the Deviation Review Board (DRB). Attend DRB as Manufacturing representative to present the preliminary information for the deviations, non-conformities and/ or abnormalities and participate in the assessment/ rating of the deviation. Lead investigation by facilitating discussions with relevant SMEs from all departments in the course of deviation investigation. Interact with customers in the form of face-to-face meetings and/ or teleconferences to communicate investigation findings/ outcomes to the customer. Coordinate and collaborate cross-functionally to achieve completion of an investigation and the design of appropriate CAPA(s). Present the output from an investigation in the form of a deviation report and ensure the information populated in the deviation report is factual and accurate. Manage appropriate system to track status of open deviations/ CAPAs to ensure timely closure. Ensure timely investigation and closure of all deviation reports in support of lot disposition. Support customer and regulatory audits; prepare and own storyboards for deviations and present during audits. Perform any other duties as assigned by your Lead/ Manager.

Key requirements:

Degree in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/ Microbiology) related disciplines. Work experience in a cGMP regulated environment and prior technical knowledge in batch biopharmaceutical processing as well as manufacturing process deviation investigation. Strong technical communication, writing skills, and presentation skills. Excellent interaction skills with internal stakeholders, external customers and auditors. Proficiency in standard Microsoft Office applications e.g. MS Word, Excel and PowerPoint. Familiarity with FDA & EMA GMP and regulatory requirements. Influential and ability to lead and facilitate discussions in a cross-functional investigation team.

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: R61952

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