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.
- Solid 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

📌 Junior Quality Analyst (Chennai)
🏢 ValGenesis
📍 Chennai