Pratibha Patil

• Manage Quality system activities with wiki documents(EDMS).
• Handling CAPA and creating Remediation Plan
• Facilitate KT sessions and Internal audits and Mock audits/prep sessions for QMS and Medical Device solutions aligned to

ISO-13485 - Medical devices - Quality management system.

ISO- 14971- Medical device - Application of Risk Management

ISO- 9001- Quality Management System software life cycle.

• Food and Drug Administration(FDA) 21 CFR Quality Regulation.
• Regulation EU No.2017/745 on Medical devices.
• Regulation EU No.2016/679 General data protection.

• Content Reviewing process for one of the leading social media Company(client).
• Reviewing the cases based on the client protocol which also includes government aided rules for countries.
• Depending on the result of our review we act on the cases if they must be allowed on social media, should be suspended for
  violating any of the protocol.
• Monitored and executed quality assurance procedures on client
  product-Mobile Applications.
• Audited quality compliance with internal policies and external regulations, ensuring consistent adherence across departments.

• Client provides UK business internet and telecommunication services including business broadband, leased lines, mobile and television services.
• Selene was set up to provide the broadband and telephone services.
• Planning process was totally based on the service request received by the customer, it involved the product details including bandwidth, type of service, speed
  etc.
• Cases mainly involved decision making on circuits used, ports and handling critical situations on unpaid cases.