NovintiX
Website:
novintix.com
Job details:
Job Title: Change Facilitator
Industry: Pharmaceutical / Life Sciences / MedTech
Location: Coimbatore, Tamil Nadu, India
About the Company:
NovintiX is a global engineering and digital transformation company with operations across multiple countries that helps leading organizations build innovative products and solve complex business challenges. We work across industries such as Medical Devices, Life Sciences, Healthcare and Manufacturing, delivering engineering, digital, and consulting solutions.
Position Summary
The Change Controller supports the development and maintenance of global change control processes to ensure regulatory compliance, operational efficiency, and audit readiness. This role focuses on cross-functional coordination, accurate documentation, and timely execution of changes using tools such as COMET and Windchill. The ideal candidate is detail-oriented, well organized, proficient in managing change control activities, demonstrates initiative and ownership, thinks beyond the immediate task at hand, understands the broader business and process context, and is capable of working independently while collaborating effectively with cross-functional
Key Responsibilities
- Create, manage, and maintain change control records in COMET, Windchill, or similar systems based on SME inputs.
- Prepare accurate and complete change control documentation, ensuring clarity of scope, risk, impacted functions, and implementation plans.
- Coordinate pre-change activities, including stakeholder alignment meetings and Change Control Board (CCB) presentations.
- Identify and coordinate with assessors, approvers, and impacted stakeholders throughout the change lifecycle.
- Collaborate with QA, Engineering, Manufacturing, Planning, Procurement, R&D, Regulatory, and other cross-functional teams to ensure successful implementation.
- Track change control progress, monitor timelines, and follow up on pending assessments, approvals, and implementation activities.
- Coordinate amendments, extensions, and updates while ensuring compliance with internal procedures and regulatory requirements.
- Maintain complete, accurate, and audit-ready documentation for all change control activities.
- Generate status reports and communicate progress, risks, and issues to relevant stakeholders.
- Ensure compliance with GMP, GxP, FDA, EMA, MDR, and internal quality management system requirements.
- Demonstrate initiative, ownership, and attention to detail while proactively identifying potential risks and driving timely completion of change control activities.
- Contribute to continuous improvement of change control processes and support operational excellence initiatives.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, Pharmacy, or a related discipline.
- 3–5 years of experience in Change Control within the Pharmaceutical, Life Sciences, or Medical Device industry.
- Hands-on experience with COMET, Windchill, or similar Change Management/PLM systems.
- Good understanding of GMP, GxP, FDA, EMA, MDR, and Quality Management Systems.
- Strong documentation, coordination, communication, and stakeholder management skills.
- Ability to manage multiple priorities in a fast-paced, cross-functional environment with minimal supervision.
Application Process/Equal Opportunity Statement:
To apply for this position, please submit your application through job portals or by email to hiring@novintix.com. Applications received through these channels will be reviewed, and shortlisted candidates will be contacted for screening and interview rounds. Only shortlisted candidates will be contacted for further steps.
NovintiX Technologies is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, or any other protected characteristic.
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