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Validation Manager

3 months ago

Bengaluru, Karnataka, India ValGenesis Full time

ValGenesis is seeking a dedicated and experienced Validation Manager to take ownership of the validation process for one or more product lines. This role involves hands-on work, team management, and a strong focus on quality and timely delivery.

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.
  • Team management
  • 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.
  • 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.

Requirements

  • BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical , or related field.
  • Good domain understanding of the industry areas where the product will have an impact.
  • Good knowledge of user profiles in the industry and usage scenarios
  • Good knowledge of regulatory guidelines and practices including GMP, FDA, ISO, etc.
  • 12+ years of Computer System Validation and Product Software Validation testing experience in a regulated environment.
  • Good knowledge of Product development life cycle
  • Understanding of GMP, FDA, and ISO regulations
  • Good knowledge of testing tools and Microsoft Office products
  • Self-motivated, and willing to learn new concepts, technologies, and products quickly.
  • Excellent interpersonal, writing, and communication skills, and troubleshooting skills.
  • Passionate about testing, Validation, and product quality
  • Able to train and help colleagues with less experience; be able to lead bigger projects.

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.

Today, we continue to push the boundaries of innovation - enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.

The Team You'll Join

  • Our customers' success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity's quality of life, and we honor that mission.
  • We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.
  • We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.
  • We're in it to win it. We're on a path to becoming the number one intelligent validation platform in the market, and we won't settle for anything less than being a market leader.

How We Work

ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.