Senior Regulatory Compliance Officer

3 days ago

Ellore, Andhra Pradesh, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 25,00,000
Compliance Specialist Job

About the Role:

This is an exciting opportunity to join our organization as a Compliance Specialist. As a key member of our team, you will be responsible for ensuring compliance with regulatory standards and developing validation plans.

Key Responsibilities:

  • Develop and implement validation plans, risk assessments, and test plans to ensure compliance with GxP, GDPR, FDA, and 21 CFR Part 11.
  • Review and prepare validation artifacts, including Summary Reports and Requirement Traceability Matrix (RTM).
  • Maintain knowledge of System Life Cycle, Agile methodology, AIML concepts, and Quality Management Systems (QMS).
  • Collaborate with cross-functional teams to ensure compliance and quality.

Requirements:

To succeed in this role, you will need:

  • 4-7 years of experience in compliance and validation roles.
  • Strong knowledge of GxP, GDPR, FDA, and 21 CFR Part 11.
  • Familiarity with System Life Cycle, Agile methodology, AIML concepts, and QMS.
  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
  • Experience in Healthcare, CRO, or Life Sciences environments.

Preferred Qualifications:

  • Experience with SaaS validation, automation, and vendor audits.
  • Participation in internal/regulatory audits.
  • Strong documentation skills (SOPs, templates, work instructions).
  • Familiarity with risk-based validation and data management.

Benefits:

We offer a competitive package that includes:

  • A comprehensive salary and benefits program.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

Educational Qualification:

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