IT Validation Manager - ERP and Non-ERP Systems at Sigma-Aldrich Chemicals Private Limited

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

0.0

Posted On

08 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, ERP Systems, Non-ERP Systems, Quality Assurance, Regulatory Compliance, Validation Protocols, Risk Assessments, Validation Projects, Cross-functional Collaboration, Negotiation, Process Challenge, Communication, Veeva, SAP, Annex 11, 21 CFR Part 11

Industry

Biotechnology Research

Description

Validation Owner of ERP and Non-ERP Systems (all genders) Your Role: Are you ready to take charge of validation processes for both ERP and non-ERP systems across our organization? We are seeking a motivated and critical mindset Validation Owner to lead our quality assurance efforts. In this pivotal role, you will ensure compliance with regulatory requirements and industry standards, driving the validation strategy for our systems. You will play a crucial role in the development and implementation of validation protocols, ensuring that all systems meet quality and compliance standards. Your expertise will be essential in conducting risk assessments, managing validation projects, and collaborating with cross-functional teams to align on best practices. We are looking for someone who is proactive, a critical thinker, and not afraid to engage in negotiations with stakeholders. Your ability to challenge existing processes and communicate effectively with senior management will be key to your success in this role. If you are passionate about quality assurance and validation and want to make a significant impact in a dynamic environment, we invite you to apply. Who You Are: Education: Bachelor’s or Master’s degree in relevant fields (Engineering, Information Technology, Life Sciences, or related disciplines). Experience: Proven strong experience in validation processes for ERP and non-ERP systems for 5-9 years. Regulatory Knowledge: Excellent understanding of regulatory requirements and industry standards for system validation, including Annex 11 (new), Annex 22 (new), and FDA 21 CFR Part 11. Validation Expertise: Strong knowledge in validation expertise, with experience in developing and executing validation strategies, protocols, and reports. Validation expertise in Veeva and SAP systems (TEMPO, Quattro and others) is a plus. Critical Thinking: Exceptional analytical and problem-solving skills, with a willingness to challenge existing processes. Interpersonal Skills: Excellent communication and negotiation skills, with the ability to collaborate effectively with cross-functional teams and senior management- with empathy & emotional intelligence Motivated: A self-starter who thrives in a fast-paced environment and is empowered to drive quality initiatives. Language Skills: Fluent in English; proficiency in other languages is a plus. Why Join Us? Be part of a forward-thinking organization committed to quality and compliance. Collaborate with a diverse team of professionals dedicated to excellence. Drive impactful changes in a global context.

Responsibilities

The role involves owning the validation process for both ERP and non-ERP systems, ensuring compliance with regulatory requirements and industry standards by leading the validation strategy. This includes developing and implementing validation protocols, conducting risk assessments, and managing validation projects across the organization.