Compliance Specialist

Greetings from HCL

Hiring for "Compliance - QMS"

Experience - 6- 14 years

Notice period - Immediate to 90 days

Location - Bangalore / Chennai / Noida /Pune / Hyderabad

JD;

Stakeholder Management

• Excellent Oral and Written communication.
• Extensive experience in directly working with customers

Periodic Review

• Hands on experience in conducting Application Periodic Reviews
• Manage Periodic review processes including scheduling, conducting and reporting of Periodic reviews
• Documenting process gaps and working with stakeholders to rectify them
• Experience in analyzing risks and working with stakeholders for mitigations

Deviation

• Performs Deviation Creator role and maintains the Deviation lifecycle and creates identified Deviations as a Deviation record in QMS system
• Collaborates with multiple stakeholders in recording, managing deviation
• Supports as required in Route Cause Analysis (RCA) process using QMS specified method to manage Deviation
• Ensures Deviations are linked to CAPA and Effectiveness Check
• Ability to communicate and manage multiple stakeholders across different spectrum

CAPA

• Adept in using CAPA management module using TrackWise or any eQMS system
• Creates requests for “Due Date Extension” or “Cancellation” requests for CAPA as per the stakeholder request
• Tracks all CAPA, Deviations to closure without any timeline deviations
• Provides trend analysis of CAPA to identify patterns and to measure effectiveness check
• Proactively escalates necessary communications to ensure CAPA is timely managed
• Proactively communicates and excels in stakeholder management

Supplier Assessments

• Extensive knowledge and experience in conducting supplier assessments

Interested candidates please drop an email to "kushmathattanda.baby@hcltech.com"

Regards,

Kushma