Compliance Documentation Associate

3 days ago

Mumbai, Maharashtra, India Cipla Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Total Years of Experience

1-3 Years

Department

Cipla Medtech

Designation

Team Member Medical Devices

Qualification

Biomedical Engineering

Role

Compliance Documentation Associate

Responsibilities:

  • Handling Documentation of Medical Devices.
  • Observance of the laid down standard operating procedures (SOP) within Cipla Medtech, including laboratory safety.
  • Custodianship of Product specific Protocol & Reports for development studies from department associates
  • Compilation of Device Master File for Domestic Market, Standalone medical devices products & standalone diagnostic instruments.
  • Working closely with CFT team for documentation process & submission.
  • Auditee in Internal Audit for Department & compliance actions to be taken with the help of Team.
  • SOP Upgradation proposal for department.
  • Data Lifecycle custodianship for developed product which are filed.
  • Responsible for Change Control Preparation, CR Initiation, co-ordination with Cross functional Teams for change evaluation process required for Change Approval, Driving Implementation Activities of Change through Action Plan & Record.
  • Maintain Change Request Log & Approved Change documents file.
  • Preparation of specifications & Standard Testing Procedures for Individual Raw Materials & Standalone medical device products.
  • Maintain Effective File & Obsolete File for revised & Old Medical Device Specifications-STP Documents along with Specification-STP Log Sheet maintenance.
  • Responsible for Operating Cipdox Software /Trackwise Application/CMT Manual Form for Change Control Activities.
  • Responsible for operating Emsigner for Digital Document signatures.
  • New Launch Device documentation readiness

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