Rutuja Deokar
Quality Assurance Specialist
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About
Experienced in Quality Assurance department
Expertise in complete implementation of SOP&APQR preparations and review,QMS documents(Change control, Deviation,Market Complaint,CAPA)
Review of Technology transfer documents likeTTD, Specifications,MOA,protocols,COA.
Audit handling & compliance like USFDA, FDA audit, WHO-GMP audit, ISO 9001:2015,ISO 13485:2016,CE Marking,other vendor audits and other party audits.
Experienced in Regulatory submissions for different countries like EU MDR filings,ROW countries,ASEAN Countries.Well known about NDA,INDA,ANDA,CTD,eCTD.
QRM & Continuous Quality Improvement
Reviewing Artwork,labels and leaflets
Preparation & Reviewing of BMR,BPR and apex documents(SMF,VMP, Quality Manual)involved in manufacturing processes.
Internal Audits and Gap analysis.
Process validation.
Experience
Experienced in Quality Assurance department
Expertise in complete implementation of SOP&APQR preparations and review,QMS documents(Change control, Deviation,Market Complaint,CAPA)
Review of Technology transfer documents likeTTD, Specifications,MOA,protocols,COA.
Audit handling & compliance like USFDA, FDA audit, WHO-GMP audit, ISO 9001:2015,ISO 13485:2016,CE Marking,other vendor audits and other party audits.
Experienced in Regulatory submissions for different countries like EU MDR filings,ROW countries,ASEAN Countries.Well known about NDA,INDA,ANDA,CTD,eCTD.
QRM & Continuous Quality Improvement
Reviewing Artwork,labels and leaflets
Preparation & Reviewing of BMR,BPR and apex documents(SMF,VMP, Quality Manual)involved in manufacturing processes.
Internal Audits and Gap analysis.
Process validation.
Education
Master of Pharmacy in Quality Assurance Techniques
