Junior Quality Analyst

ValGenesis; Chennai District; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

ValGenesis is seeking a Quality Management professional to oversee QMS processes, ensure ISO 9001:2015 and ISO 27001:2013 alignment, and support regulatory compliance for computerised systems. The role covers change controls, validation, audits, and continual improvement.

The candidate should have engineering or pharma background with SDLC knowledge, strong communication, and project management skills. Willingness to work within a dynamic pharma tech environment is essential.

Qualifications

• Engineering or Pharma degree with strong SDLC understanding.
• Knowledge of testing/validation and quality is preferred.
• Experience with audits and regulatory thinking is preferred.

Responsibilities

• Oversee Quality Management Processes in line with ISO 9001:2015 and ISO 27001:2013.
• Support GxP computerized systems and risk-based audits.
• Manage change controls, deviations, and validation documentation per ValGenesis standards.
• Ensure 21 CFR Part 11 compliance for computerized systems.
• Conduct internal and vendor audits; report to Head of Quality/Management.
• Drive continual improvement and Quality by Design initiatives.
• Assist training with planning and execution of training for ValGenesis.

Skills

SDLC understanding

Quality management

Auditing & compliance

Documentation & record-keeping

Analytical thinking

Project management

Communication skills

Education

Engineering or Pharma degree

Tools

GAMP 5

Information Security basics

Job description

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

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.