Expert Compliance Advisor

2 days ago

Tiruchi, Tamil Nadu, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000

Job Description:

We are seeking an experienced Compliance Expert to join our organization. As a Compliance Expert, you will play a vital role in ensuring adherence to regulatory standards and maintaining high-quality systems.

Key Responsibilities:

  • Compliance and Validation: Hands-on experience in compliance and validation roles is essential for this position. You should have strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5. System validation aligned with regulatory standards is also required.
  • System Life Cycle and Methodologies: Well-versed with System Life Cycle and hands-on experience with Validation approach, Agile methodology, AIML concepts are necessary for success in this role.
  • Testing/Validation Experience: Review and preparation of Test Plans, Validation Plans, Risk Assessments, Requirement Traceability Matrix (RTM), Summary Reports, and understanding of the defect lifecycle and validation deliverables are key skills required.
  • Tools and Technologies: Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems is essential.
  • Quality & Domain Expertise: Knowledge of Quality Management Systems (QMS) and experience in Healthcare, CRO, or Life Sciences environments are required.

Preferred Skills :

  • 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.

Educational Qualification: Any Graduate.

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