Job Reference: J5631520
Updated On: 05/07/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Quality Engineer to join a leading pharmaceutical company based in the Norfolk area. As the Quality Engineer you will be responsible for the Quality, regulatory and technical approach on validation and risk management activities within New Product Introduction and commercialised products.
Key Duties and ResponsibilitiesYour duties as the Quality Engineer will be varied however the key duties and responsibilities are as follows:
1. You will review and approve validation and technical risk assessment documents as required ensuring compliance across manufacturing and laboratory equipment.
2. You will drive continuous improvement of the validation and risk management processes to ensure that they are effective, value added and efficient.
3. As the Quality Engineer, you will oversee all Quality Engineering deliverables to time, cost and quality standards to ensure good performance in allocated programmes.
4. You will conduct internal and external supplier audits in line with the organisations supplier management procedures to ensure product quality.
Role RequirementsTo be successful in your application to this exciting opportunity as the Quality Engineer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Science or Engineering related discipline.
2. Proven industry experience in Process Validation, Risk Management and Quality Engineering practises.
3. A working knowledge and practical experience with validation regulatory requirements, 21 CFR Part 820 and associated GMP guidance set by the FDA.
Key Words: Quality | Validation | Engineering | Risk Management | NPI | New Product Introduction| Pharmaceutical | Medical Device | Product Validation | Quality Management Systems | QMS | GMP | 21 CFR Part 820 | ISO 13485 |
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