Validation Specialist - DACH Region
- Employer
- NonStop Consulting
- Location
- Vienna
- Salary
- €40 - €50 per hour
- Closing date
- Jun 12, 2019
View more
- Sector
- Science, Life Sciences, Cell and Molecular Biology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
Validating software for various projects is a good motivation for you and knowing that your work has a direct impact in the lives of patients suffering from life threatening diseases gives you the extra drive. If this is the case, the following job description is directly addressing you.
You can also look at it as a great opportunity to get a proverbial foot through the door with some of Pharma's biggest names so that you'll never run out of offers for good work.
Design, Author, and Execute Computerized System Validation (CSV) - according to GAMP 5 guidance - especially on Analytical Laboratory Test Equipment and other Lab Information Systems
Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents.
Translate technical information and requirements into qualification/validation test design
Qualifications, Skills & Experience:
Bachelor's Degree; scientific background preferred
At least 1-4 years of pharmaceutical of FDA related validation experience
Good knowledge of GMPs, 21CFR Part 11, USP 1058 - and other relevant industry regulations and guidance
Strong interpersonal skills and demonstrated ability work independently
Organized and task oriented
Excellent written and oral communication skills - especially on technical topics
Self-directed and motivated individual who is able to operate in a rapidly changing business environment
Customer-oriented, conducting job function with a primary focus on customer satisfaction (internal & external) and ability to deal with customer complaints
Must have a strong command of Microsoft Office Word and Excel and Adobe Acrobat, Microsoft Project
Ability to build consensus among team of stakeholders
Excellent critical thinking/analytical and problem solving skills
Experience with a multitude of laboratory equipment a plus
Work Conditions:
Lab Environment (may need to follow Personal Protective Equipment and Safety Polices);
Company
Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries.
Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery. Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.
The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors.
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