Compliance Specialist

Designation:

Experience:

Location:

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:

• Proven experience developing and managing Quality System Processes
• Ability to conduct internal audits or manage external audits as an auditee
• Knowledge of the software development and testing process, especially for Agile development
• Conduct CAPA meetings and follow the CAPA process.
• Train cross teams on Quality System processes and manage the LMS tool.
• Excellent written communication skills in English
• Familiarity with regulated software requirements and standards
• Familiarity with Vendor and Tools Evaluation.
• Familiarity with various regulations like ISO 9001 and 27001, FDA 21 CFR Part 11, GDPR, and EU GMP Annex 11
• Familiarity with document control, change management, training management, deviation management, audit management, supplier management, software lifecycle management, and Management review.

Education Qualification:

• Bachelor’s degree, preferably in Computer Science, Electrical Engineering, Physics, Math, or any other related discipline with an MS degree being a plus.
• ISO:9001 and ISO:27001 certification is an added advantage

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.