Deviation investigation intern
1 week ago
Deviation Investigation InternApply locations SG - Tuas, Singapore
Time type: Full time
Posted on: Posted Yesterday
Job requisition id: R63722
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 inSingapore ? 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 Manufacturing intern role is responsible to support the Deviation Investigation teams under supervision:
Systems & c GMP ExpertiseLearns and performs well/defined procedures.
Attain a basic understanding of c GMP’s and compliance in a GMP manufacturing setting performing both supervised and unsupervised tasks.
Regular use of Standard Operating Procedures, logbooks and protocols.
Problem Analysis / Decision MakingBasic decision making, knows when to seek help and who to contact.
Able to identify situations which may require escalation to supervisor.
Planning / CommunicationOrganizes and plans assigned daily activities to ensure timely completion of assignments.
Documents all work as it occurs.
Communicating to a level where appropriate questions are asked to increase understanding of role.
Deviation ExpertiseParticipate by shadowing investigators during investigation and closure of deviations. The completion of a deviation report includes and is not limited to root cause analysis, product impact assessment and design of appropriate CAPA(s).
Participate by shadowing investigators in on-field investigation to collect data and interview relevant parties to determine the root cause of deviation.
Participate by shadowing investigators in the activities to be performed with relevant subject matter experts (SMEs) from all departments in the course of deviation investigation. Collaboration between departments is required for the completion of an investigation and the design of appropriate CAPA(s).
Able to utilize the deviation database to perform recurrence analysis on the event of deviation.
Daily maintenance of major/minor deviation trackers with updating of new deviations and removal of closed records.
Send out biweekly updates of deviation status to DIT and QA team.
Follow up with investigators on causes of delays for deviation records.
Support investigators in providing c GMP batch records scan and logbooks, data mining of historical information.
To identify areas of improvement within the DIT team.
Any other duties as assigned by your Supervisor/Manager.
Job RequirementsDiploma / 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 Power Point.
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.#J-18808-Ljbffr
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