Muthukumarasamy V

Dear Sir/Madam,Good Morning, I have been working in the pharmaceutical industry and Clinical Research in QA department for 19 years, and I have a strong track record of success in this area. I was responsible for a wide range of QA activities, including:

Conducting audits of Pharma and clinical research sites and vendors to ensure compliance with GMP, Good Clinical Practice (GCP) guidelines,

Ø Developing and implementing QA procedures and protocols

Ø Training and mentoring QA staff

Ø Investigating and resolving QA issues

Ø Maintaining and improving the QA system

I am confident that I have the skills and experience that you are looking for in a QA professional. I am a highly motivated and results-oriented individual with a strong commitment to quality.

I have attached my resume for your review.

Thank you for your time and consideration

Professional Experience

• Overall Audit and Quality compliance at facility 
• Preparation &

  • Handling of Regulatory Audit like WHO, EU-GMP, ISO &

  • Customers. 

• Preparation &

  • Review of SOP’s

• Handling of SMF, Incidents, Deviations &

  • CAPA, Change controls etc. 

• Training management for all employees. 
• Conducting and coordinating of Self inspections. 
• Review of Process, Cleaning &

  • Equipment validation. 

• Handling of supplier Quality and vendor file management. 
• Handling of Recall &

  • Returned Products. 

• Handling of Market Complaints.
• Handling of OOS/OOT/STR/OOC etc.
• Audit &

  • Qualification of Clinical research laboratory 

Educational Summary

(Dr.MGR Medical University)

April 2004MBA(Pharma)MSU

( Manonmanium Sundaranar University)

March 2011Clinical Research (BA/BE)Deepam Hospital & Research InstituteMarch 2020