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Validation consultant
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Role
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Quality consultant
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Technology
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Quality
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Profile
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As an Validation Consultant, you are responsible for: validation plan, risk analysis, user requirements, test scripts & scenarios, validation protocols, change controls, manuals, training records, … You support the testing and consolidate the test results. You implement validated new processes, methods, equipment, software programs in a heavily-regulated and monitored environment. Your work domain can be software-, process & equipment- or method-validation. Your approach complies with the requirements imposed by the law or the client.
Watch the movie:
Want to see what our consultants are doing every day? Then watch this movie: Ordina Validation Academy @ Alcon
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Function Requirements
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Bachelor or Master level;
Interest in IT is a must;
Relevant experience in one of the following fields:
Legislation:
21CFR part 11 electronic records and electronic signatures;
GxP regulation (mainly GMP and GLP);
Methodology:
LSV (Lab System Validation);
CSV (Computer System Validation);
GAMP (Good Automated Manufacturing Practices);
You can work using a 'Science Based Quality Risk Management' Approach;
You are familiar with working in a heavily-regulated environment like pharmaceuticals, chemicals, the food industry;
Knowledge of project management (Prince2) is a plus;
You have excellent communication skills;
You have a strong customer focus and service-oriented attitude;
You are an initiator of new ideas;
You have a strong analytical mentality/conceptual way of thinking;
You are flexible and stress-resistant.
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What Ordina offers
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- Challenging projects within a versatile circle of customers
- An open no-nonsense company culture with room for personal initiative
- A high tech environment with focus on knowledge and innovation
- A great number of workshops, trainings and events in cooperation with Ordina Academy of the Ordina Education Center
- Real possibilities to grow within the company and to clearly define your career on the basis of an Human Talent Management program
- Regular team events and social company events
- An attractive salary in accordance to the market situation with a wide remuneration package such as a company car…
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Apply for this job
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