CSV- QC Application Support Engineer- Cork, Ireland - 6 Months

Cork  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

Empiric Solutions are currently seeking for an experienced CSV consultant- Engineer for a leading and global client in Ireland.

The following Senior QC Support Engineer requires in depth knowledge of QC Enterprise applications and will perform administration, support, configuration, development, and routine Master Data maintenance. The ability to script in SQL and/or LIMS Basic is a plus. The successful candidate will coordinate across functional areas and wear many hats' in a fast paced environment.

Responsibilities

  • Analysis and Solution Definition
  • Perform Business System Analysis and technical lead duties for implementation projects
  • Support the validation of applications including but not limited to risk assessments, technical guidance, discrepancies, Use Cases, URS, UAT, Qualification Reports, template verifications, Baseline configurations, Change Control, SOPs, System Retirement Plans & Protocols, validation reports.
  • Maintain current knowledge of industry standards and regulatory requirements for computerized systems
  • Identify and implement improvements to the IT applications where appropriate
  • Draft and edit process flow diagrams
  • Propose technical solutions and architectures
  • Develop User Requirements working closely with the Business Process Owner(s) and Business Analysts
  • Develop Functional Requirements and Configuration Specifications

Technical Recommendation and Testing

  • Lead User Acceptance Testing/Conference Room Pilots, workshops and documents gap analysis
  • Manage iterative development of system as needed to ensure system meets business needs
  • Work closely with CSV personnel to develop risk appropriate testing strategy.
  • Review and edit validation deliverables including but not limited to: Risk Assessment, IQ, OQ, PQ, MQ, regression testing, and Retirement Plans,
  • Drafts and Executes Validation protocols as appropriate

Project Execution

  • Enforcement of project deadlines and schedules, as required.
  • Drafting Project Specific deliverable including but not limited to Project Implementation Plan, meeting agendas, minutes, Change Requests, and presentations, as required.
  • Communicates and applies project standards.
  • Manages resources in accordance with project schedule.
  • Promotes positive attitude among team members
  • Promotes best practices and standards, and reviews deliverable to ensure highest standard of delivery

Experience/Skills

  • Minimum of 5 years' experience supporting and implementing Enterprise application(s) as an Administrator (eg, LIMS, Empower)
  • Firm understanding of computer system validation, GMP predicate rules, 21CFR Part 11/EU Annex 11, and Data Integrity concepts
  • Clear verbal and written communication skills to provide customers with a positive experience
Start date
ASAP
Duration
6-12 months contract
From
Empiric Solutions
Published at
27.10.2018
Project ID:
1656800
Contract type
Freelance
To apply to this project you must log in.
Register