30 Jul
|
NovintiX
|
Tamil Nadu
30 Jul
NovintiX
Tamil Nadu
Job Title: Change Facilitator Industry: Pharmaceutical / Life Sciences / MedTech
Coimbatore, Tamil Nadu, India
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.
The Change Controller supports the development and maintenance of global change control processes to ensure regulatory compliance, operational efficiency, and audit readiness. 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
Prepare accurate and complete change control documentation, ensuring clarity of scope, risk, impacted functions, and implementation plans.
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.
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.
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.
~ Ability to manage multiple priorities in a fast-paced, cross-functional environment with minimal supervision.
NovintiX Technologies is an equal chance 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.
📌 Event facilitator (Tamil Nadu)
🏢 NovintiX
📍 Tamil Nadu