Our client is a Global Leader in Medical device manufacturing having their GIC in Gurgoan.

Key Responsibilities:

• Assist in strategic planning and project timeline management.
• Prepare and review software validation documents for CSV projects.
• Conduct regulatory assessments to determine GxP and Part 11 relevance.
• Collaborate with IT, Engineering, Quality, and other technical disciplines.
• Maintain the system's validation state throughout its lifecycle.
• Develop GxP deliverables, SOPs, Work Instructions, and critical documentation.
• Provide production support for systems and manage Change Request Management (ChaRM).
• Publish and maintain project communications to stakeholders.
• Provide training to the OUS Team on validation expectations.

Requirements:

• Bachelor's degree in a business/technical area or equivalent.
• Minimum of 5 years' experience in Computer Systems Validation within the pharmaceutical/medical device GMP environment.
• Experience in CSV/SDLC, including traditional waterfall and agile, as well as GAMP 5 application.
• Regulatory knowledge (EMEA, FDA, GxP, etc.).
• Operational area experience (R&D, Manufacturing, IT, etc.).
• Systems knowledge and experience (AERS, ERP, LIMS, etc.).
• Strong interpersonal and communication skills.
• Ability to work independently and within a team.
• Strong problem-solving and organizational skills.
• Keen sense of maturity, judgment, and diligence.
• Ability to work accurately under time constraints.
• Trustworthy and professional with a commitment to confidentiality.

Don't miss this opportunity to contribute to the ongoing success of the medical device industry.
You can also apply now by sendng your resume to [email protected]