Compliance Specialist

3 weeks ago

india, IN 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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