Site Investigation Team (Experiences in Quality & Investigation)

Biocon; Gelang Patah; On-site; MYR 50,000 - 70,000; Full time

Job summary

A leading biotechnology company in Gelang Patah is looking for a Site Investigation Team member to address non-conformances, analyze data for root cause analysis, and support quality management systems. The role requires a Bachelor's degree in biotechnology or a relevant engineering field and involves collaboration across multiple quality assurance tasks. One must possess strong analytical skills and experience in handling deviations, CAPA proposals, and investigation reports.

Qualifications

• Bachelor's degree is required.
• Experience in quality and investigation is essential.
• Familiarity with statistical analysis tools is preferred.

Responsibilities

• Provide support for reported deviations and non-conformances.
• Perform site walks to the plant as needed.
• Conduct data analysis for root cause analysis.

Skills

Quality Analysis

Statistical Analysis

Root Cause Analysis

Investigation Skills

Education

Bachelor's degree in biotechnology or any Engineering Course

Job description

Site Investigation Team (Experiences in Quality & Investigation)

• Responsible to involve and provide support for any reported deviations / non-conformances
• Responsible to perform site walk to the plant, whenever required.
• Provide support for data collection, data analysis using appropriate Statistical Analysis tools and interpretation of data as part of root cause analysis
• Analyzing the Root Cause for the non-conformances using appropriate Investigation Tools.
• Analyzing the historical non-conformances related to the current events and assessing the effectiveness
• Proposing appropriate CAPA based on the root cause of non-conformances.
• Handling of investigation reports for non-conformances; i.e deviations, OOS, OOT and market complaints using appropriate investigation tools.
• Handling of investigation for manufacturing investigation (Phase II) for OOS/OOT/OOCT and market complaints
• Responsible for providing interim reports for any delayed investigation, whenever applicable.
• Supporting the QMS elements for closure in Trackwise, as originator.
• Responsible to perform personnel interview for Human Error related non-conformances.
• Responsible in handling DI related non-conformances for manufacturing related investigation.
• Bachelor's degree in biotechnology or any Engineering Course.