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
