Validation Lead

Vor Ort
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flag_no Schweiz

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We are looking for a Validation Lead

Industry: Leading Pharmaceutical Company

Contract opportunity from until possible extension

Location: Home office & 50% for the rest of the year, will need to be or travel to Zurich on a regular basis.

Our contacts within the company take into account our applications as a priority.

The role of the Validation/SDLC Lead will provide compliance/validation leadership and direction to the MDM project in Software Deployment Life Cycle (SDLC)/Computer System Validation (CSV) standards and practices.

The main objectives of this role will focus on ensuring that the validation strategy and document structure for the MDM Project is in alignment with the ongoing SAP project and that it enables a globally validated and controlled MDM environment.

This will be accomplished by

Developing SDLC/Validation/Testing/Migration strategy - Validation Plan (VP) for the MDM system in line with the above objectives and as agreed with the SO, CSQA and Global IT Validation CoE.

Executing the SDLC/Validation/Testing/Migration strategy per the VP, with support of assigned project team members and testing services.

Managing Validation and SDLC activities per the defined Role and Responsibilities in the VP, assuring the thoroughness of Validation and SDLC planning and delivery in the MDM project.

Participate on cross functional teams to validate/verify, implement, and maintain regulated (Example: GxP, JSOX, Data Privacy) and/or non-regulated parts of the MDM system. This will require close cooperation with Global IT Compliance and CSQA

Providing validation/SDLC training to stake holders and team members in the MDM project as necessary.

Managing relationships with key customers and stake holders to ensure the total validation/verification solution delivered to the customer meets/exceeds expectations.

Leading the validation/verification strategy by either working with the offshore testers to develop the strategy or develop the strategy, then obtaining approval from the business and/or IT in alignment with Global IT Testing CoE.

If applicable, manage the project team's offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements

Analyze test results and ensure requirement objectives and documentation standards have been met

Developing an IT System maintenance process with the System Owners organization

Ensuring all Validation/SDLC deliverables are completed and stored appropriately

Leading resolution efforts when issues are identified and escalate appropriately.

Supporting the response to, and remediation of corrective actions/test failures.

Ensuring that the IT System Validation/testing takes in account as well the countries where the current infrastructure is still different (EUCAN/emerging market; US, Ireland/Bray and Japan).

Ensuring the project validation/testing timeline is met per specified agreement and/or scope change

Ensuring SDLC/CSV activities are conducted with quality in mind, in a cost effective manner and compliance with applicable regulatory requirements

Your Profile

Experience from Pharma, SAP and Master Data Management.

If you are interested, I invite you to send your CV to Charlotte Curtelin, Recruitment Responsible: (see below)