Ashvini Pote

• Process Expert/Subject matter expert/Squad Leads.
  • Coordinate with internal management and provide consultation on process queries.
  Coordinate with team members, and resolve their queries.
  Identifies areas for improvement and works with the continuous improvement team.
  Train and guide the team on updates in regulations or processes.
  Ensure spot checks, quality checks, and compliance with regulations, SOPs, and guidance documents.
  • Represent in audits/inspection from GDV
  *Monitored key performance indicators KPIs, providing regular reports to senior management on process performance.
• Promotes on-time global regulatory reporting.
• Timely complaint record closure.
• Serves as a SME between complaint handling teams and cross-functional partners (e.g., Regulatory, QAC, MTO, and HA enquiries) to ensure seamless communication and alignment of safety priorities.
• Escalates potential safety issues as they are identified.
• As a squad lead, I encourage team members to take ownership of their work while providing guidance and support to ensure timely and high-quality case handling.

• Train and guide the team on updates in regulations or processes.
• Ensure spot checks, quality checks, and compliance with regulations, SOPs, and guidance documents.
• Represent in audits and inspections from GDV.
• Has a good understanding of processes in VC, Pharma, and Surgical Franchise.
• Process case files according to Standard Operating Procedures (SOP).
• Reassess the data, ensure accurate product selection, and assign required event code(s) in the system.
• Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, and investigation findings).
• Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries, and launch requirements.
• Schedule expedited and periodic regulatory reports based on local and international reporting regulations.

· Process Complaint files according to Standard Operating Procedures (SOP).

· Work with affiliate offices to ensure required dataset has been received/requested.

· Re-assess the data, ensure accurate product selection and assign required event code(s) in the system.

· Complete initial and follow-up reporting assessments as information is received (initial report, follow-up questionnaires, phone calls, investigation findings).

· Respond to Manufacturing Quality Assurance (QA) requests and Health Authority inquiries

· Launch required quality investigation records.

· Schedule expedited and periodic regulatory reports based on local and international reporting regulations.

Provide support in reconciliation activities and audit as required.

· Evaluate and escalate potential safety issues to management.

• Work experience in Primary packing

• Work experience in Primary packing

• Work experience in secondary packing