Designation: Compliance Specialist

Preferred Experience: 5+ Years

Job Summary:

We are seeking an experienced Compliance Specialist with 5+ years of experience in healthcare, pharmaceutical, clinical research, or regulated environments. The ideal candidate will be responsible for ensuring organizational compliance with regulatory requirements, industry standards, and quality management frameworks, including GxP, HIPAA, FDA 21 CFR Part 11, and GAMP 5. The role involves supporting audits, risk assessments, validation activities, compliance monitoring, and regulatory inspections.

Key Responsibilities:
- Ensure compliance with applicable GxP regulations, including GMP, GCP, and GLP requirements.
- Monitor and maintain adherence to healthcare compliance standards and regulatory requirements.
- Lead and support internal, external, client, and regulatory audits.
- Review and maintain policies, SOPs, work instructions, and compliance documentation.
- Ensure compliance with FDA 21 CFR Part 11 requirements related to electronic records and electronic signatures.




- Support computerized system validation (CSV) activities in accordance with GAMP 5 guidelines.
- Conduct compliance risk assessments and develop mitigation plans.
- Collaborate with Quality Assurance, IT, Clinical Operations, and Regulatory Affairs teams to ensure regulatory compliance.
- Monitor changes in healthcare regulations and industry standards and implement necessary updates.
- Participate in vendor qualification, supplier audits, and third-party compliance assessments.
- Investigate compliance deviations, CAPAs, and audit findings and drive remediation activities.
- Provide compliance training and awareness programs for employees.
- Support HIPAA compliance initiatives, including privacy, security, and protected health information (PHI) management.
- Assist in inspection readiness activities and regulatory submissions.

Required Skills & Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, Hea

📌 Compliance Specialist (Pune City)
🏢 Aventior
📍 Pune City