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