Compliance Specialist

4 days ago

Hyderabad, Telangana, India HCLTech Full time
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

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