The Role
The Module Lead will oversee the validation of products, manage team duties, and ensure delivery focus on product quality and timelines while collaborating with engineering and testing teams.
Summary Generated by Built In
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/watch?v=tASq7Ld0JsQ
About 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.
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
Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company.
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.
Top Skills
Oq
Pq
Qms
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The Company
What We Do
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.
