Compliance Specialist

Greetings from HCL

Hiring for "Compliance - QMS"

Experience - 4- 14 years

Notice period - Immediate to 90 days

CTC- Open for discussion

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