
[Apply in 3 Minutes] Compliance Specialist
1 week ago
Job Description
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 [Confidential Information]
Regards,
Kushma
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