Posted:1 day ago| Platform: Foundit logo

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Job Description

About ValGenesis

ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watchv=tASq7Ld0JsQAbout the Role:We are looking for a great Module Lead, to join our Validation team. You will coordinate with the rest of the team working on different layers of the infrastructure. Therefore, a commitment to collaborative problem solving, sophisticated design, and quality product is important.Your primary focus will be based on the below description

Responsibilities:

  • Taking ownership of Validation of one or more product lines
  • Hands on work at an individual capacity leading to deliverables
  • Review Product Requirements including Epics, User stories, Software Requirements etc.
  • Author test cases in OQ and PQ protocols in line with the requirements and QMS guidelines
  • Create realistic test cases and test data based on customer usage scenarios.
  • Review Test cases, data, and Test designs.
  • Diligently work with Product, Engineering and Testing teams to gain understanding of Product functions.
  • Work in a highly collaborative team environment, with communication across many team members.
  • Good understanding of the company QMS standards
  • Author documents in accordance with the QMS guidelines
  • Manage Internal and External Audits on Validation queries for respective products
  • Daily and Weekly Status Reporting
  • Strong Oral and written communication skills

Team management duties:

  • Scope the work and develop estimates.
  • Allocate team members and collaborate with other Managers for assigning people to work.
  • Guide the team members in their areas of work, from domain knowledge, product knowledge and QMS procedures perspective.
  • Review the work of team members to ensure quality and timelines are met.

Delivery focus

  • Product quality and delivery timelines are the key focus.
  • Ensure implementation of techniques to meet both quality and timelines.

We're on a Mission

In 2005, we disrupted the life sciences industry by introducing the world's first digital validation lifecycle management system. ValGenesis VLMS revolutionized compliance-based corporate validation activities and has remained the industry standard.

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ValGenesis logo
ValGenesis

Software/Validation Management

Irvine

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