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February 22 2018

    Job details

Job Opportunity: COMPUTER SYSTEM VALIDATION ENGINEER:FRS Recruitment

Job description:


   » Job ID.:15322710
   » Employer ID.:RI/FRS27092
   » Published:13-FEB-2018
   » income:NEGOTIABLE
   » Job location:CAVAN, CAVAN
   » Employment Type:CONTRACT

 

Senior Validation Engineer required to review the computer system Validation processes and procedures for the overall site, GxP Risk Management process and ensure that appropriate mitigation steps are implemented to meet current GxP regulations

The systems are as follows
Enterprise resource planning business system (ERP) SAP Business 1 .
QC Empower laboratory chromatography data management system. CDS.
Retrospective validation/Gap analysis of all other potential GxP computer systems on site.
Main tasks & The main responsibilities are:

Manage the computer system Validation process for the overall site.
Manage GxP Risk Management process and ensure that appropriate mitigation steps are implemented to meet current GxP regulations
Plan and manage the cGMP validation test and documentation phase of the implementation with risk analysis used to define critical GMP components to be validated
Prioritize qualification activities in line with the project schedules and business needs.
Develop templates as required for Validation documentation

Prepare reports of executed protocols for review.
Generate SOP's / other documentation as applicable
Manage all Validation documentation created from the process
Manage overall signature process for all documentation
Manage Validation change control on the project
Develop procedures and processes for the complete computer validated state lifcycle, Data Integrity, Audit Trail review, Disaster recovery etc.

expertise / practice:

3 - 5 years in a Computerized Systems Validation function (CSV).
Excellent technical English verbal and written expertise
CSV practice in an established QA/IT function preferably in the pharmaceutical/healthcare industry
Strong expertise of GAMP5, CSV, Project Life Cycle and GxP Regulations
practice drafting, reviewing and/or approving validation documentation VMP, URS, RA, IQ, OQ, PQ, UAT, SAT and VSRs.
Previous practice generating Risk Assessment Matrices for validation projects.
practice in validating pharmaceutical CDS and ERP system computer/control systems a distinct advantage.
Excellent attention to detail, self-motivated and capability to work to tight or changing deadlines
Work with existing in-house validation team
This job originally appeared on RecruitIreland.com

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Cavan
Company Type Employer
Post Date: 02/13/2018 / Viewed 10 times
Contact Information
Company: FRS Recruitment


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