Compliance Specialist

3 days ago


India Sycamore Informatics Inc. Full time

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.



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