Dr. Ajay Kumar Singh Email & Phone Number

Oman

Usa

Mumbai

Quality Assurance And Regulatory

 To conduct the analyst validation activity of all new joining & maintain its documents as per requirement. To prepare cleaning validation protocol of sampling tools, conduct cleaning validation activity as per protocol and prepare report of the same. To prepare process validation protocol, conduct process validation activity as per protocol and prepare report of the same. To prepare analytical method validation protocol, conduct analytical method validation activity as per protocol and prepare report of the same. To conduct IQ, OQ & PQ of all QC instruments / equipments. To prepare Specifications, STPs, GTPs and protocols of Intermediate / FG / Stability / RM /PM. To review critical SOP’s of QC department for improvement. To prepare, review and provide documents to regulatory department as per requirement. To maintain all the instruments / equipments in calibrated & operating condition on or before due. To conduct glass ware calibration and maintain all the records as per SOP. To conduct the activity of preparing working standards, procuring new reference standard as well as reference cultures and maintains all the records of same as per SOP. To prepare document and maintain the quality system as per procedure and provide support to plant during regulatory inspection. To provide training & guidance to all QC persons & maintain the documents as per SOP. To conduct OOS and OOC in QC and maintain all relevant documents.

Ahmedabad, Gujarat

Head QA & RA

Mumbai, Maharashtra

Ph.D, Quality Control

Activities and Societies: Cricket

Master Of Science In Chemistry, Organic Chemistry, 2Nd

Activities and Societies: debate team Graduated with Honors in Chemistry and Botany.

Education record