Samirkumar Patel Email & Phone Number

India, Phareast And Midle East, Africa Region.

Mumbai Area, India

To manage entire contract manufacturing sites pertaining to Quality aspects including vender qualification and market complaint.To be review DMF and dossier for drugs. Impliments or update the quality documents time to time as per various drug regulatory.To lead the regulatory audits time to time. Leading person of audit team. Guide the QC and QA team members time to time. Core team member pertaining to qulity, international business as well as prodution planning.

Indrad, Gandhinagar.

To manage entire Microbiology section and review all inprocess and SFG reports. To be manage GLP and validation and calibration activity. Time to time major involvement in various regulatory audits.

Ahmedabad Area, India

To establish new Quality Control Lab as per regulatory norms.To be review of QC documents. To review Quality documents. Lead the various regulatory audits. To manage and review of Analytical Method Validation for various formulation and bulk drug products. To execute QC lab. with microbiology section.Active involvement in Q-10 project. To be prepare Quality Documents including validation and stability. To perform chemical analysis of inprocess sample as well as RM and FP too. To get… Show more To establish new Quality Control Lab as per regulatory norms.To be review of QC documents. To review Quality documents. Lead the various regulatory audits. To manage and review of Analytical Method Validation for various formulation and bulk drug products. To execute QC lab. with microbiology section.Active involvement in Q-10 project. To be prepare Quality Documents including validation and stability. To perform chemical analysis of inprocess sample as well as RM and FP too. To get excellence command on instrumentation section pertaining to HPLC, GC, IR, LCMS ect. Show less

Moraiya, Ahmedabad.

To manage entire QC Microbiology section with validation activity as per regulatory norms.Also active involvement in RM and FP analysis and Regulatory documents preparation. Sharpen the technical as well as managerial skill under Dr. Rustom Mody and Dr. Patankar.

Charcharwadi Vasna, Ahmedabad

To be perform validation of environment monitoring, water system validation as per various regulatory aspects. To be perform Sterility and BET analysis including validation activity.Team member of TGA audit team under guidance from Mr.Kalpesh Bhalja, GM-Operations.

Master Of Science (M.Sc.), Microbiology, General, Second

Doctor Of Philosophy (Ph.D.)

Bachelor'S Degree, Microbiology, General, First