Sandeep Kumar Madupoju

Agile and adaptable team player with around 11 years of experience in the pharmaceutical industry. Has sound knowledge in Quality Management System, Document Management System, Training Management, Audit and Compliance, Data Integrity Assessments, and Risk Assessments. Good Experience on electronic quality systems, Change Controls, Deviation Management, Market Complaints and CAPA management.

Seeking challenging assignments in Pharmaceutical Industry.

Ø Worked on the qualifications of eLMS, eQMS, and eDMS modules

Ø Preparation of GAP Analysis for eLMS, eQMS & eDMS Modules.

Ø Preparation of Traceability Matrix for eLMS, eQMS & eDMS Modules.

Ø To monitor and to trace the change controls, Deviations and CAPA (Corrective action and Preventive action) in Veeva Vault application.

Ø To assess, approve and close the change controls and CAPA in in Veeva Vault application.

Ø Ensure the launch and follow up workflow process in the electronic Documentation Management System until final approval.

Ø Preparation, review and approval of GMP (Good Documentation practice) documents such as SOPs, batch records, investigation reports etc.

Ø Support the review process and ensure the content of new or revised Quality documents is reviewed.

Ø Preparation, review and approval of Annual Product Quality Reports (APQRs).

Ø Managing GxP Training requirements, preparation of curriculum and learner roles for cross functional departments.

Ø Preparation of GxP Training Matrix annually and ensuring all the employees are trained.

Ø Managing/ providing access to the users in electronic Learning Management System and electronic Document Management system.

Ø To Prepare and review the trends for Change controls, Deviations and CAPAs.

Ø Handling of Self-inspections (Internal Audits).

Ø Handful of knowledge on handling of Market complaints and conducting investigation.

Preparation of the Quality Management Review document on a monthly basis

Ø Auditing cross functional departments as a part of Self inspection procedure.

Ensuring the overall quality aspects of the serialization process

Ø Writing response along with CAPA proposals to customer audit observations.

Ø Ensuring compliance in all the activities

• Ø Awarded as the best employee from Quality Assurance department for the year 2018 at Granules India Limited.

Date of Birth   : 02-12-1988

Father Name : M. Shivaiah

Permanent Address : H. No. 2-3-479/B, Plot no. 10 and 11, flat no 202, Sri Laxmi Nilayam, Sai Nagar, Nagole, Uppal mandal, Medchal-Malkajgiri dist., Telangana - 500068.

Sex / Marital status : Male / Married

I hereby declare that all the information given here is true to the best of my knowledge, and I bear the responsibility for the correctness of the above-mentioned particulars

Regards,

Madupoju Sandeep Kumar.