Compliance Specialist

Designation : Compliance Specialist

Experience : 3 - 5 years

Location : Remote (India)

Job Responsibility :

Assist with Quality System development, training, and process. Assist with internal audits to assess compliance. Represent or assist SI in external audits. Participate in the CAPA process.

Roles & Responsibilities :

• Assist and work to create, review, and update Quality System procedures, assisting the Quality Management Leads and Director, Quality Management.
• Provide or manage Quality System training
• Managing all quality-related documents (procedures, specifications, records etc.) with version control and electronic approvals.
• Conduct RCA meetings for the CAPA process
• Assist with internal audits to ensure SI follows the Quality System procedures and to identify gaps and areas for improvement.
• Represent or assist SI in external Audits
• Identifying, assessing, and controlling risks to product quality, patient safety, and data integrity.
• Evaluating and managing vendors and suppliers to ensure they meet quality standards and other inputs.

Requirements :

Education Qualification :

Professional Qualification / Certifications :

Exposure to ICH-GCP guidelines and Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records, electronic signatures and computer systems validation.