3.0 - 5.0 years

2 - 5 Lacs

Kolkata

Work from Office

Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Oversee and manage essential Quality Management System documentation, including Design History Files (DHFs), CAPAs (Corrective and Preventive Actions), and change controls. Regulatory Compliance: Ensure strict adherence to FDA QSR (21 CFR Part 820), ISO 13485, EUMDR (EU Medical Device Regulation), and other relevant regulatory norms. Audit Support: Actively support internal and external audits (e.g., FDA, Notified Body), ensuring readiness and effective follow-up. Supplier Quality: Manage supplier qualification, monitoring, and quality agreements to ensure materials and services meet specifications. Training & Calibration: Coordinate and maintain training records and calibration programs to ensure compliance and operational effectiveness. Quality Improvement: Collaborate on product development initiatives and drive continuous quality improvements across the organization.

Posted 4 days ago

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Immediate hiring Consultant/ Assistant Manager/Manager Role Shell Infotech

5.0 - 10.0 years

10 - 20 Lacs

Noida, Gurugram, Greater Noida

Work from Office

Have in-depth knowledge of governance, risk, and compliance, including internal auditing, audit standard, risk and compliance, cyber security review, policy review, ISO 27001, ISMS etc. Perform testing of IT Application Controls, IPE, and Interface Controls through code reviews, IT General Controls review covering areas such as Change Management, Access Management, Backup Management, Incident and Problem Management, SDLC, Data Migration, Batch Job scheduling/monitoring and Business Continuity and Disaster Recovery. Perform Risk Assessment, identification, and Evaluation of Controls, prepare process flow diagrams and document the same in Risk & Control Matrix. Perform business process walkthrough and controls testing for IT Audits. Performing planning and executing audits, including - SOX, Internal Audits, External Audits Conducting controls assessment in manual/ automated environment Prepare/Review of Policies, Procedures, SOPs Maintain relationships with client management and the project Manager to manage expectations of service, including work products, timing, and deliverables. Demonstrate a thorough understanding of complex information systems and apply it to client situations. Use extensive knowledge of the client's business/industry to identify technological developments and evaluate impacts on the work to be performed. Coordinate effectively and efficiently with the Engagement manager and the client management keeping both constantly updated regarding projects progress. Collaborate with other members of the engagement team to plan the engagement and develop relevant workpapers/deliverables. Perform fieldwork and share the daily progress of fieldwork, informing supervisors of engagement status

Posted 6 days ago

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Quality Control Officer Axalta

4.0 - 7.0 years

6 - 10 Lacs

Savli

Work from Office

Key Responsibilities: Conduct routine product and process inspections to ensure compliance with quality standards. Monitor production processes and identify deviations or defects. Document inspection results and maintain accurate quality records. Collaborate with production and QA teams to implement corrective actions. Ensure compliance with industry standards, safety regulations, and company policies. Participate in internal audits and assist with external audits. Maintain and calibrate testing equipment. Provide training to staff on quality procedures when necessary.

Posted 1 week ago

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Massive Hiring For 401k US Retirement - Bangalore !!!! Job Seeks 4u Consultancy Services

2.0 - 7.0 years

4 - 6 Lacs

Bengaluru

Work from Office

Role: Process Specialist Exp: Min 2+ years into 401K-US Retirement Salary: Max 6.5 LPA Must have experience: Defined Contribution/Defined Benefit Location: Bangalore Immediate joiner to 30 Days

Posted 1 week ago

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