Deviation Investigation Intern

Deviation Investigation Intern

Apply locations SG - Tuas, Singapore

Time type: Full time

Posted on: Posted 27 Days Ago

Job requisition id: R63226

Lonza is a global leader in life sciences. The Singapore site is a mammalian cell culture manufacturing facility for the contract development and production of multiple biopharmaceutical products, including monoclonal antibodies (mAbs), cellular therapeutics, and other recombinant proteins.

Apart from supporting day-to-day tasks, the MM-DIT intern should expect to be involved in the technical investigation and writing process of Manufacturing deviations.

The MM-DIT Intern should also expect to gain a fundamental understanding of bioprocessing, deviation investigation workflow and tools, and end this assignment with invaluable skills and knowledge in the biopharmaceutical industry.

Responsibilities:

• To attain a good understanding of current Good Manufacturing Practice (cGMP) and its application.
• To support MM DIT’s day-to-day activities according to Environment, Health and Safety (EHS) guidelines and in a compliant manner.
• To perform daily maintenance of the deviation tracker, which includes updating new deviation records and removing closed deviation records.
• To keep key stakeholders (DIT and Quality Assurance (QA)) informed of the deviation status.
• To follow up with investigators on causes of delays for closure of deviation records.
• To support investigators with the provision of GMP documents and data mining of historical information to aid with the investigation.
• To participate by shadowing investigators during the investigation and closure of deviations. The completion of a deviation report includes, but is not limited to, root cause analysis utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, causal branching, event and causal factor charting, Failure Mode, Effect and Cause Analysis (FMECA), product/quality impact assessment/justification, and design of appropriate CAPA(s) with effectiveness checks, where required.
• To participate by shadowing investigators in on-field investigation to collect data and interview relevant parties to determine the root cause of the deviation.
• To participate by shadowing investigators in the activities to be performed with relevant Subject Matter Experts (SMEs) from various disciplines in the course of the deviation investigation. Collaboration between departments is required for the completion of an investigation and the derivation of appropriate Corrective and Preventive Action (CAPA(s)).
• To perform recurrence analysis for deviation.
• To perform data mining, interpret, and present data to support continuous improvement projects with adherence to the respective project timelines.
• To identify areas of improvement within the DIT team.
• To support other sub-functions within MTT as required.
• To perform any other duties as assigned by Supervisor/Manager.

Key Requirements

• Diploma/Degree in Engineering (Chemical/Biochemical) or Science (Biochemistry/Chemistry/Microbiology) related disciplines preferred.
• Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint.
• Strong organizational and time management skills.
• Excellent written and verbal communication skills.
• Excellent interpersonal skills.
• Action-oriented and team player.
• Ability to facilitate changes and be flexible to learn.
• Excellent work record (includes tardiness and absenteeism record).

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.