Hse/ Risk Assessment Quality Engineer
1 week ago
One of the reputable pharmaceutical industrial companies is looking for a professional HSE/ Risk Assessment & Quality Engineer who is expert in establishing risk analysis plans, handling suppliers & sub-contractors and products registration.
**Key Responsibilities**:
- The Risk Assessment & Quality Engineer is responsible for setting policies and procedures for the establishment of plans for risk analysis concerned with the company's products, suppliers and sub-contractors.
- You'll be accountable for recommending and implementing risk management solutions with respect to regulatory documentation and submissions and making sure that Risk Analysis becomes an integral part of the company's Quality Management System.
- One of your main duties is to ensure that Good Health and Safety practices are implemented and maintained in production activities.
**Key Requirements**:
- A university degree in Quality, Engineering or a scientific discipline.
- Min. of 5 years of experience in Quality Operations, Qualifications & Validation, Quality Systems and Quality Risk Management.
- Min. of 5 years of experience in **_biopharmaceutical business_** industry with full working knowledge of ICH Q9, ICH Q10 and the FDA, WHO and EMA requirements for the manufacture and control of pharmaceuticals and biological products and risk analysis.
- The right caliber for the role must have a proven experience in root cause analysis in manufacturing and control issue troubleshooting and understanding of regulatory processes for vaccines.
- Holding certifications in HSE is a huge plus.
- Excellent communication skills & Ability to work effectively and efficiently across company functional areas and with external third parties.
- Fluent English is a MUST.
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