Regulatory Compliance Specialist

18 hours ago


Nagpur, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Job Summary

The company seeks a qualified professional to assume the position of Compliance Advisor. The successful candidate will be responsible for ensuring adherence to regulatory standards across various systems and processes.

About the Role:

  • To ensure compliance with GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations by conducting thorough reviews and validation audits.
  • Prepare test plans, validation plans, risk assessments, requirement traceability matrices, and summary reports.
  • Participate in internal and regulatory audits to identify areas for improvement and ensure ongoing compliance.
  • Maintain strong knowledge of quality management systems (QMS) and industry best practices.
  • Collaborate with cross-functional teams to implement changes and improvements.

Requirements:

  • Minimum 4-7 years of experience in compliance and validation roles.
  • Strong understanding of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations.
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
  • Experience in Healthcare, CRO, or Life Sciences environments.

Education:

Bachelor's degree or equivalent required.

Key Responsibilities

The Compliance Advisor is expected to take on the following key responsibilities:

  1. Conduct regular audits to verify system compliance with relevant regulations.
  2. Develop and maintain accurate records of audit results and compliance status.
  3. Collaborate with other departments to ensure effective implementation of compliance measures.

Professional Qualifications

  • Demonstrated expertise in GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5 regulations.
  • Proven ability to analyze complex data and make informed recommendations.


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