Regulatory Compliance Specialist

1 day ago

Hyderabad, Telangana, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 35,00,000

Regulatory Compliance Role Summary

About This Opportunity

This is a critical role within our organization, responsible for ensuring adherence to regulatory requirements and industry standards.

The selected individual will be expected to play a pivotal part in maintaining our company's reputation by upholding the highest standards of compliance.

Key Responsibilities
  1. Stakeholder Management:
  • Excellent communication skills are essential for this role, as they will be required to effectively interact with various stakeholders on a regular basis.
  • A minimum of direct experience working with customers is necessary.
Periodic Review:
  • Hands-on experience conducting Application Periodic Reviews is mandatory.
  • The ideal candidate will be responsible for managing Periodic review processes, including scheduling, conducting, and reporting.
  • Documenting process gaps and collaborating with stakeholders to rectify them will also be a key responsibility.
  • Analysis of risks and development of mitigation strategies will be an ongoing task.
Deviation:
  • Creating Deviation records in our Quality Management System (QMS) will be a crucial duty.
  • Collaboration with multiple stakeholders in recording and managing deviations will also be required.
  • The selected individual will support the Root Cause Analysis (RCA) process using our specified method.
  • Ensuring deviations are linked to Corrective Action Preventative Actions (CAPA) and Effectiveness Checks will be a key responsibility.
CAPA:
  • Adept use of CAPA management modules using TrackWise or eQMS systems will be necessary.
  • The ideal candidate will create requests for Due Date Extensions or Cancellations for CAPA.
  • Tracking all CAPA and Deviations to closure without timeline deviations will be a key responsibility.
  • Providing trend analysis of CAPA to identify patterns and measure effectiveness checks will also be a duty.
  • Proactive escalation of communications to ensure timely CAPA management will be expected.
Supplier Assessments:
  • Extensive knowledge and experience in conducting supplier assessments will be beneficial.
About Us

We are an exciting opportunity for a highly motivated individual to join our team in Hyderabad, India.

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