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16 سبتمبر 2013

Qualificationvalidation engineer Leap29



Qualificationvalidation engineer


My client has a mission to help its industrial clients to modernise and improve the performance of their industrial sites. With their unique organisational structure and principal strength they aim to provide expertise on production processes and research methods as well as infrastructure.

The end client is one of the leading global pharmaceutical giants and have recently invested around euro3 billion in three biotech projects located in Germany.


The role will require you as the qualificationvalidation engineer to work with a team of engineers in making sure the computer system validation for manufacturing systems is compliant with regulations. You will be accountable for managing and coordinating a team.


The project is a 3 year project if you are suitable you will need to have all of the following criteria


Minimum of degree qualification in relevant science andor engineering discipline

Minimum 10 years39 experience of validation in a regulated Pharmaceutical environment

Understand GAMP standards 21 CRF Part 11 and applicable regulatory guidelines

Produce CSV plans specifications protocols and reports.

Execution of computer system validation and other pharmaceutical manufacturing equipment commissioningvalidation IQOQPQ protocols

Review completed protocols ensuring cGxP compliance and data acceptability. Generation review and approval of SOPs.

Conduct system risk assessments

Strong knowledge of Biotechnology facilities and equipment

Experience of working in compliance with cGMP Standards

Technical writing experience

Qualification of an manufacturing execution system andor automation system

Fluent in German


You will be working with one of the largest pharmaceutical companies in the world they are a reputable giant in the industry employing over eighty two thousand worldwide. The project is a large investment to build a greenfield Biotech manufacturing site.


If you want to take your career to the next level in a highly desirable location then this is the move for you. If you feel that you have the relevant skills and experience then please apply by following the relevant links provided



Status Contract Minimum Experience 0 years Location Bavaria INTERNATIONAL nbsp Advert Published 16 Sep 2013 Expiry date 16 Oct 2013 Leap29 Ref. No.

J34130 OilCareers Ref. No.






via http://qatar.tanqeeb.com/jobs-in-qatar/engineer/003268643.html


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