CSV Engineer- MES West Dublin
Long term contract opportunity to join a premier Biopharma
manufacturing organisation based in West Dublin on an exciting new
project.. Our client seeks an experienced CSV Engineer, proficient in
computerised Manufacturing Execution Systems (MES) to track and
document the transformation of raw materials through to finished
goods. If you are in search of new projects in Biopharma we have the
opportunity for you.
Responsibilities
Data Integrity Testing / ERES Preliminary Tests
Media and Backups- Verify the availability of system and backup media
items required for the system.
Test Setup- Create tests accounts and test data as required
Configuration Tests
Computer Hardware and Software- Verify details of computer hardware,
software and printers controlling the equipment.
Windows Security- Verify the configuration of security, including
date/time, settings on the Windows system comply with Ipsen policy
requirements.
User Privileges - Confirm privileges assigned to users - defined,
approved, and configured correctly on system.
User Review -Verify all users - active and with access to Windows
system and application are approved and assigned correct role / group.
Backups Configuration Verify the data backup tool(s) are configured to
back up the required data, to the required destination at the required
frequency. -
Electronic Signatures - Confirm the eSignature configuration are
defined, approved and configured correctly on the system.
System Upgrade Tests
Document / verify implementation of data integrity related changes
associated with system upgrade including the migration / preservation
of data from the legacy system, verification that changes have been
correctly implemented and the computerised system is ready for
operational use.
Domain Logon and Security, Users, User Groups and Privileges,
eSignatures, Report Templates, Methods
Legacy Data
Verify legacy data from the old system is securely retained, complete
and legible on new system
Test Wrap-Up
Tidy up data created during execution of this protocol and disable all
test accounts. Confirm a concluding drive image of the system is
performed. PC tidy-up, system image
Supplemental Compliance
Develop and execute OQ based on standard compliance tests adjusted for
Karl Fischer functionality, configuration and 5 PCs.
Compliance Assessment
Develop compliance assessment for system.
Compliance Summary Report
develop summary report detailing assessment and findings.
Process Data Map
Develop process/data flow map for KF system with the aid of quality
control personnel.
Risk Assessment
Review Risk Assessment for Online Data Review client document (phone
number removed)-FOR for system and update where required to address
new functionality and/or review practice.
Online Review Form
Obsolete QC API KF Electronic Data & Audit Trail Review client
document and incorporate checks into procedure (specific for product).
Improvements Review
Explore feasibility and benefits of implementing or preparing system
for future implementation of following during system upgrade.
Database Reorganisation, Data Archiving, Use of eSignature for review
and approval of Determinations 3 Item Work Tasks Days, Disaster
Recovery Position: CSV -MES- West Dublin
CSV Engineer- MES West Dublin
Long term contract opportunity to join a premier Biopharma
manufacturing organisation based in West Dublin on an exciting new
project.. Our client seeks an experienced CSV Engineer, proficient in
computerised Manufacturing Execution Systems (MES) to track and
document the transformation of raw materials through to finished
goods. If you are in search of new projects in Biopharma we have the
opportunity for you.
Responsibilities
Data Integrity Testing / ERES Preliminary Tests
Media and Backups- Verify the availability of system and backup media
items required for the system.
Test Setup- Create tests accounts and test data as required
Configuration Tests
Computer Hardware and Software- Verify details of computer hardware,
software and printers controlling the equipment.
Windows Security- Verify the configuration of security, including
date/time, settings on the Windows system comply with Ipsen policy
requirements.
User Privileges - Confirm privileges assigned to users - defined,
approved, and configured correctly on system.
User Review -Verify all users - active and with access to Windows
system and application are approved and assigned correct role / group.
Backups Configuration Verify the data backup tool(s) are configured to
back up the required data, to the required destination at the required
frequency. -
Electronic Signatures - Confirm the eSignature configuration are
defined, approved and configured correctly on the system.
System Upgrade Tests
Document / verify implementation of data integrity related changes
associated with system upgrade including the migration / preservation
of data from the legacy system, verification that changes have been
correctly implemented and the computerised system is ready for
operational use.
Domain Logon and Security, Users, User Groups and Privileges,
eSignatures, Report Templates, Methods
Legacy Data
Verify legacy data from the old system is securely retained, complete
and legible on new system
Test Wrap-Up
Tidy up data created during execution of this protocol and disable all
test accounts. Confirm a concluding drive image of the system is
performed. PC tidy-up, system image
Supplemental Compliance
Develop and execute OQ based on standard compliance tests adjusted for
Karl Fischer functionality, configuration and 5 PCs.
Compliance Assessment
Develop compliance assessment for system.
Compliance Summary Report
develop summary report detailing assessment and findings.
Process Data Map
Develop process/data flow map for KF system with the aid of quality
control personnel.
Risk Assessment
Review Risk Assessment for Online Data Review client document (phone
number removed)-FOR for system and update where required to address
new functionality and/or review practice.
Online Review Form
Obsolete QC API KF Electronic Data & Audit Trail Review client
document and incorporate checks into procedure (specific for product).
Improvements Review
Explore feasibility and benefits of implementing or preparing system
for future implementation of following during system upgrade.
Database Reorganisation, Data Archiving, Use of eSignature for review
and approval of Determinations 3 Item Work Tasks Days, Disaster
Recovery
We need : English (Good)
Type: Permanent
Payment:
Category: Others
