Compliance Specialist

2 days ago


Hyderabad, Telangana, India HCLTech Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Greetings from HCL

Hiring for "Compliance - QMS"

Experience 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 ""

Regards,

Kushma



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