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 :

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 mandatory

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.