Quality Engineer Validation Consultant - QMS - Pharmaceuticals

QUALITY ENGINEERS VALIDATION CONSULTANT/LEIDEN, NETHERLANDS/8 MONTHS CONTRACT/40 TO 69 EUR (PER HOUR)

Optimize systems and processes that are aligned with Mentor's strategy and mission effecting continuous quality improvement.

PRINCIPAL DUTIES AND RESPONSIBILITIES

- Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements.
- Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
- Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
- Responsible for pFMEA documentation and leading pFMEA meetings.
- Reviews validations documentation (eg. IQ, OQ, PQ and verification studies).
- Leads or is team member of CAPA investigation and action plans.
- Leads or is team member of Internal audit observation investigation and action plans.
- Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product.
- Ensures that software validations are performed according to applicable FDA guidelines.
- Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.

EXPERIENCE AND QUALIFICATIONS:

- University/Bachelor level in engineering or science
- Basic statistical analysis tools
- Relevant experience
- Experience within Pharmaceutical/Medical Device companies
- Knowledge of software and process validations
- Knowledge in Statistics
- Sufficient knowledge about computer systems and programming with Crystal Reports

Non Technical Skills and Additional Details:

- Pro Active
- troubleshooting and Risk Assessment/Risk Management minded
- Tact
- High level of accuracy
- Flexible and Service minded
- Able to identify and simplify complex issues
- Communication skills
- Fluent in English, Dutch
- Strongly theoretical role (reviewing documentation, identify gaps and solving these, making the company 'audit-proof'.

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

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