B
Biocon Sdn Bhd
Senior Executive, Chemical Process
Skills
Compliance
3 months ago
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Important information
Contract type:
Permanent
Location:
Johor Bahru, Johor, Malaysia
Work mode:
Onsite
Published on:
10 August 2026
What they need
Key Responsibilities:
- Prepare, review and maintain GMP documentation include but not limit to batch records, protocols, reports, risk assessment, impact assessment, Standard Operating Procedures and Equipment Operating Procedures
- Ensure accuracy, completeness, and compliance of all documentation with applicable GMP requirements
- Prepare e investigation reports and implement appropriate corrective and preventive actions (CAPA)
- Support facility expansion projects and equipment installation activities
- Review qualification protocols and reports to ensure compliance with GMP requirements
- Ensure compliance with current Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards
- Follow Environmental Health and Safety (EHS) policies and procedures at all times
- Support internal and external audits, inspections, and compliance initiatives.
- Update and maintain Batch Manufacturing Records and other GMP documentation in accordance with ALCOA++ principles.
- Adherence to Standard Operating Procedures, Operational Control Procedures
Qualifications:
- Bachelor's degree in chemical engineering / manufacturing engineering / Biotech Engineering
- Years of Experience: 4 years to 6 years
- Preferred Industry: Industry with GMP background (added advantage)
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