The Role
Support and maintain quality management processes and computerized systems validation for a life‑sciences digital validation platform. Manage change controls, deviations, audits (internal and vendor), document review/approval, training, and information security compliance per ISO, GxP, and 21 CFR Part 11 requirements.
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.valgenesis.com/about
About the Role:
Responsibilities
- Overall change and review responsibility for Quality Management Processes in line with the standard requirements of ISO 9001:2015 and ISO: 27001:2013.
- Knowledge of Risk-Based Approach to Compliant GxP Computerized Systems - GAMP® 5 that would aid in facing customer audits
- Support the product development life cycle for computerized systems with change controls, deviations management ensuring that relevant documentation is in place and maintained according to the ValGenesis requirements.
- Understanding of computerized systems validation, lifecycle management and 21 CFR Part 11 requirements.
- Conduct and manage the internal audits including vendor audits and report to Head of Quality / Management
- Customer focus with eye for details, analysis and continual improvements.
- Managing with day to day quality control activities areas per quality plan requirements and track them to closure.
- Up to date with the latest development of the standards and other regulatory needs in the pharmaceutical industry and maintain compliance to the QMS.
- To review and approve the various validation documents both internally as well as during product deployment for customers. The documents are routed in a workflow with predefined SLA and the expectation is to review thoroughly without any defects or missing content.
- Support on Information Security Management System in terms of review of documents and ensure that is line with the requirements of security standards.
- Improve compliance through continual improvement programs across the organization and Quality by design.
- Support training department in terms of training plan, conduct of training and management for the ValGenesis.
Requirements
- Engineering Graduate or a Pharma Graduate with a good understanding about SDLC.
- Prefer CBSC education with a good knowledge of computers and programming.
- Knowledge of testing and validation and quality is preferred.
- Knowledge of Information Security and associated functions is preferred.
- Excellent communication skills (Both written and oral)
- Customer Management and inter personal Skills.
- Self-starter, well organized and self-motivated.
- Strong analytical and project management skills.
- Confident and dynamic personality.
- Attitude to learn and perform new areas including life sciences domain, Cloud, product development and other support functions
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.
Skills Required
- Engineering Graduate or Pharma Graduate with a good understanding of SDLC
- Knowledge of Risk-Based Approach to Compliant GxP Computerized Systems (GAMP 5)
- Understanding of computerized systems validation, lifecycle management and 21 CFR Part 11 requirements
- Overall change and review responsibility for Quality Management Processes aligned to ISO 9001:2015 and ISO 27001:2013
- Conduct and manage internal audits including vendor audits
- Experience with Quality Management Systems (QMS) and maintaining compliance
- Excellent written and oral communication skills
- Customer management and interpersonal skills
- Self-starter, well organized and self-motivated
- Strong analytical and project management skills
- Attitude to learn new areas including life sciences domain, Cloud, and product development
- Prefer CBSC education with good knowledge of computers and programming
- Knowledge of testing, validation and quality (preferred)
- Knowledge of Information Security and associated functions (preferred)
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
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.
