Empower CDS Business System Owner - Pharmaceutical, Open to flexibility

Stevenage, Harlow, Hertfordshire, Harlow
06 Oct 2017
04 Nov 2017
Contract Type

Empower CDS Business System Owner - Pharmaceutical, Open to flexibility

Job Purpose:

  • To serve as the central point of control (Business System Owner) for Empower CDS, and if required, for additional PDS applications developed and primarily supported by IT.
  • To ensure that the Empower CDS systems, and other PDS systems, if applicable, are fit for purpose and of an appropriate quality standard for use within the business and if supporting regulated processes, are validated and maintained in a compliant manner.
  • Provide business centric expertise for PDS Systems and related business processes (where appropriate) through project management, business process understanding, technical proficiency, system administration and compliance knowledge, throughout the system life-cycle (Initiation, Development, Implementation, and Support).
  • Provide leadership and guidance to ensure that Empower CDS and other existing PDS systems are utilized in accordance with policy, business rules are instituted and required enhancements are actively pursued.
  • Business project lead responsible for delivery of upgrades and enhancements to the Empower CDS application over lifecycle of system ensuring all technology designs and solutions meet the needs of the end users
  • Lead validation activities for Empower CDS in accordance with GMPs and 21CFR Part11 and ensure compliance over lifecycle of system
  • Work closely with scientific staff to understand their business processes
  • Provide technical expertise for troubleshooting and incident resolution to user community, as well as, liaising with IT experts for problem management - including deep dives.
  • Ensure documentation is completed in support of activities, quality incidents and regulatory requirements (e.g., system SOPs, change controls, validation documentation).
  • Responsible for fielding questions about the validation status of the Empower CDS system during a regulatory inspection or audit.
  • Maintain awareness of changes in the internal /external environments, new technologies and their potential for utilisation within Product Development & Supply.

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