Junior Quality Analyst

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