Skip to main content

CSV SME

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
36855
CSV SME - Dublin, Ireland - 6 Months Contract

How would you like the opportunity to work with in one of the largest bio-pharmaceutical projects in the country? If yes, then this is the assignment for you!

Our client is currently seeking the skills of CSV SME to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Site Subject Matter Expert for Computerised Systems Validation.
  • Responsible for developing and managing the site strategy towards CSV.
  • Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
  • Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
  • Support vendors to ensure adherence to, and application of GAMP
  • Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
  • Work cross-functionally to ensure site alignment with lifecycle requirements.
  • Support development of CSV competencies within both Validation and across the business.
  • Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
  • Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
Desirable Experience:
  • Pharma experience
  • Data Integrity
  • (EBR) Electronic Batch Record Systems
  • Writing URS’s
  • Stakeholder management
  • Reviewing and Approving SAT’s & FAT’s
If this role is of interest to you, please apply now!
#LI-SC1
Save as a job alert
List #1

Similar Jobs

Project Engineer

Salary

Competitive

Location

Waterford

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

East

Description

Project Engineer - Ireland, Waterford - 12 Month Contract  Would you like the opportunity to work alongside a global healthcare product manufacturer who are the leaders in the production of

Reference

37110

Expiry Date

01/01/0001

Dev Chauhan

Author

Dev Chauhan
Dev Chauhan

Author

Dev Chauhan
Read more
CQV Project Manager

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Compliance / Quality Assurance

Job type

Contract

Location

North America

East Coast

Description

CQV Project Manager - US, North Carolina - 6-12 Month Contract  Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV Project Manager to join their

Reference

37153

Expiry Date

01/01/0001

Mark Chaumeton Read more
Automation CSV Engineer

Salary

Competitive

Location

Copenhagen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

Automation CSV Engineer – Pharmaceuticals – Contract – Denmark Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for an Automation CSV Engineer to join their new and

Reference

36373

Expiry Date

01/01/0001

Mark Chaumeton Read more

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.