Validation Consultant
Location: Pune, Hybrid.
Status: Permanent, Full Time
Package: Competitive Salary (fixed), 5 Day Working Week, Remote/Home Working (with one-off allowance), Flexible Working, Development & Opportunity (Personal & Technical), Group Medical Policy, Group OPD Cover, Personal Accident Cover, Term Life Cover, 26 Days Leave + 9 Public Holidays + Buy & Sell Scheme, Referral Scheme.
Why are we hiring a Validation Consultant We are hiring this position due to growth in our D-Wise arm of the business.
The mission of the Validation Consultant is to support the development, review, management, and implementation of computer system validation. In addition to internal support, the Validation Consultant will serve as the Validation lead for the development, validation, implementation, and support of client hosted systems.
Who's Instem Well, we're a global provider of bespoke industry-leading software solutions and services, which facilitate the pre-clinical, and clinical phases of the drug discovery process. We have over fifteen products in our portfolio, used by over 700 pharmaceutical clients (including all the top 25!).
Instem is a unique, solutions-based organisation. We've doubled in size over the last 3 years through new business and product enhancement, but also via acquisition. Our 5-year growth plan is progressive, and we need you to help us reach that next level!
What's the culture/environment like For a global business of over 400 staff, we very much have a family feel. You'll be part of a friendly, communal, solution based, flexible environment, where you'll feel empowered, valued and accountable. We'll invest in you as a person and encourage you to take part in companywide workshops for wellbeing, mental health, critical conversations, and strengths.
What are you responsible for
- Develop, review, and implement computer system and data integrity related controlled documents
- Maintain our Validation Library to support client audits
- Participate and support Client Qualification audits as needed
- Provide direction to assure that IT applications and infrastructure components possess the necessary level of testing and required documentation to comply with applicable procedures and client requirements/expectations
- Ensure compliance with standard testing methodologies, procedures, and practices
- Prepare validation and test strategies for IT initiatives, and present to project teams
- Advise on/be involved in the performance of application, functional, usability, performance load-stress testing
- Perform documentation reviews and conduct analyses of validation process issues and testing results
- Ensure that software faults are identified and documented and coordinate with development staff to ensure testing issues are isolated and resolved.
- Ensure all necessary project-specific Computer System Validation documentation is produced
- Review of Computer System Validation artifacts for correctness, completeness, compliance, and clarity
- Adherence to the Company's Quality Management System to ensure that all work is handled Securely, Professionally and Diligently
Skills, Knowledge & Experience
- Bachelor's Degree in technology or validation related discipline (IT, Engineering)
- Experience in computer systems validation
- Understanding of SDLC processes a plus
- Strong working knowledge of testing infrastructures and the design of computer programs used to evaluate them.
- Familiarity with the Agile software development methodology
- Experience with regulated environments such as clinical and/or healthcare
- Familiarity with CFR21 Part 11 a plus
- Strong analytical and problem-solving skills
Daily, millions of lives are improved by the Instem technologies and services that have been deployed by our clients. This is a fantastic opportunity for you to help save and prolong people's lives, by doing what you do best!
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Instem stores and processes data using an Applicant Tracking System (ATS). For more information regarding our privacy policy use the following link: https://www.instem.com/privacy/
