Process Engineer

Biocon Biologics; Gelang Patah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading biotechnology company in Malaysia is seeking a professional to ensure the completion of training, manage documentation and compliance regarding employee hygiene and GMP practices, and handle corrective actions. The ideal candidate will be responsible for the issuance of annexures, documentation of Job Descriptions, and effective implementation of changes. This role requires strict adherence to safety protocols and data integrity standards, contributing to the overall quality and safety of the production processes.

Responsibilities

• Ensure completion of training for any training assigned.
• Issuance of annexure as per Document Control procedure.
• Understand personal hygiene practices to minimize contamination risks.
• Prepare, document, and provide Job Descriptions for employees.
• Register and maintain employee's specimen signature.
• Ensure proper handling of GMP/scrap documents for destruction.
• Comply with safety precautions as per mandatory EHS SOP requirements.
• Ensure compliance with Data Integrity.
• Initiate temporary and permanent change control and track impacts.
• Identify, review, and implement Corrective & Preventive actions.
• Manage incident and deviation assessments in trackwise.

Job description

Job responsibilities:

1. Ensure completion of training for any training assign.
2. Issuance of annexure as per Document Control procedure.
3. To understand on personal hygiene of the personnel entering the production, warehouse and laboratory areas so as to follow good hygiene practices to minimize risk of contamination to self and to the product manufactured in Biocon.
4. To ensure Job Description are prepared, documented and available for employee working in the respective departments.
5. To register, update as well as maintenance of employee's specimen signature.
6. To ensure proper handling of GMP/scrap documents generated for destruction.
7. To ensure compliance with safety precaution as per mandatory EHS SOP requirement.
8. To ensure compliance with Data Integrity.

1. To initiate temporary and permanent change control, assessment of impact of changes, communication of changes to relevant functions and tracking and effective implementation of changes through task management in trackwise.
2. To ensure Corrective & Preventive actions are identified, reviewed, approved, & effectiveness check is identified, and implemented, for all triggered events through trackwise application.
3. To initiate, impact assessment, identification of investigation needs, escalation, event categorization, documentation, and disposition, for incident and deviation in trackwise.