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- Learns and performs well/defined procedures.
- Attain a basic understanding of cGMP’s and compliance in a GMP manufacturing setting performing both supervised and unsupervised tasks.
- Regular use of Standard Operating Procedures, logbooks and protocols.
- Basic decision making, knows when to seek help and who to contact.
- Able to identify situations which may require escalation to supervisor.
- Organizes 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.
- Participate 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 cGMP 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.
- 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
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