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Find professionals and candidates python programmingVilas Beloshe

Vilas Beloshe

Vilas Beloshe

Quality and regulatory specialist

Talent

Dunstable, Central Bedfordshire40 GBP/hourMember since July 6, 2023

·

Hire their services

Request a quote with no obligation

quality management specialistpharmaceutical product development process improvementcmc submissionseu mdr technical file maintenanceregulatory affairs specialist

About

Expertise in implementation of ICH guidelines for product development and process improvement
Strong hold on CMC submissions for Pharma products which includes post-approval activities and new filings.
Experience of post approval submissions like EU- Type IA, Type IAIN, Type IB and Type II for MRP/DCP and National Procedures
Support health authority questions during licence change maintenance submissions.
Experience in handling customer and health authority inspections
Supportive process improvement changes
Experience in handling various regulatory databases.
Review, preparation, compilation, and submission of different variation packages to various regulatory authorities
Expertise in EU MDR technical file maintenance
QMS, Internal Audits, Process Validation,
Batch release,
Equipment and software Qualification
Computer System Validation.

Experience

Expertise in implementation of ICH guidelines for product development and process improvement
Strong hold on CMC submissions for Pharma products which includes post-approval activities and new filings.
Experience of post approval submissions like EU- Type IA, Type IAIN, Type IB and Type II for MRP/DCP and National Procedures
Support health authority questions during licence change maintenance submissions.
Experience in handling customer and health authority inspections
Supportive process improvement changes
Experience in handling various regulatory databases.
Review, preparation, compilation, and submission of different variation packages to various regulatory authorities
Expertise in EU MDR technical file maintenance
QMS, Internal Audits, Process Validation,
Batch release,
Equipment and software Qualification
Computer System Validation.

Education

Masters in formulation science

Reviews

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