Compliance Specialist

Designation: Compliance Specialist

Preferred Experience: 3+ Years 

Job Summary:

We are seeking an experienced Compliance Specialist with 5+ years of experience in healthcare, pharmaceuticals, 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, Healthcare Administration, Quality Management, Regulatory Affairs, or a related field.

● Strong knowledge of GxP Compliance (GMP, GCP, GLP).

● Hands-on experience with FDA 21 CFR Part 11 regulations.

● Strong understanding of GAMP 5 (Good Automated Manufacturing Practice).

● In-depth knowledge of HIPAA requirements, privacy rules, security rules, and PHI protection.

● Experience with healthcare compliance frameworks and industry standards.

● Knowledge of computerized system validation (CSV) methodologies.

● Familiarity with risk management and quality management systems.

● Experience conducting compliance audits and assessments.

● Strong documentation review and SOP management skills.

● Experience with CAPA, deviation management, and change control processes.

● Knowledge of validation lifecycle documentation (URS, IQ, OQ, PQ).

● Experience working with electronic systems used in regulated environments.

● Proficiency in compliance reporting and audit preparation.

Company Overview:

Aventior is a leading provider of innovative, end-to-end technology solutions, empowering businesses across diverse industries to solve complex challenges and accelerate growth. We harness the power of cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), MLOps, and DevOps to build scalable, future-ready solutions that drive measurable business outcomes.

Our expertise extends across the entire data lifecycle. We offer comprehensive data development and management services, including cloud data architecture, universal data models, Data Transformation & ETL, data lakes, user management, Analytics & visualization, and automated data capture for unstructured and semi-structured sources such as scanned documents. These capabilities enable organizations to unlock the full value of their data and make faster, more informed decisions.

At Aventior, our strength lies in combining deep industry expertise with advanced technical capabilities. Our teams work closely with clients to design and deliver tailored solutions that align with their unique business needs—whether it's optimizing operations, enhancing customer experiences, or driving strategic decision-making.

We bring a holistic, cross-industry perspective to every engagement, supported by a strong foundation in design, implementation, innovation, migration, and ongoing support. With a global delivery model, a multi-country presence, and a team of highly skilled professionals, Aventior is well-positioned to deliver consistent, high-quality outcomes at scale.