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Job Details
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CSV Specialist - Complex role

Business Type: Biotechnology Company
Job Type: Other Job Type, Validation
Job Level: Experienced (non manager)
Position: Full Time
Salary: GBP50000 - GBP65000 per annum + Bonus + Relocation + Benefits
Location: Ireland (Eire)
Reference: EM/212678/03
Closing Date: 15/04/19
Job Details:

My client has a success story like no other and is looking for a CSV Specialist to join them and be a part of it.

With a financial backing that allows them to make over 150 hires this year and a future of expansion to over 900 extra hires in the following years, you will have both the stability and the growth opportunity that you are looking for.

The role itself is highly "hands-on" so you won''t be stuck doing only documentation.

Essential Duties and Responsibilities include, but are not limited to, the following:
* Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
* Lead process improvement projects to improve the validation of computerized systems
* Coordinates with other departments or outside contractors/vendors to complete validation tasks.
* Participates in regulatory audits and communicates company''s computer validation policies.
* Assesses company''s computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
* Trains /advises less experienced Specialists and Technicians.
* Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
* Technical writing experience.
* Generation of Validation documents.
* Review and Approval of Validation documents.
* Strong attention to detail and accuracy.
* Experience in risk assessments in relation to validation activities.
* Advise and support all teams on computer validation activities.

Experience And Required Skills :
Education and Experience:
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology; will substitute relevant experience for education. Experience with process control systems necessary.

Posted: 08/04/2019 | NPJ Ref: 233421
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