Vilas Beloshe
Quality and regulatory specialist
Talent
Dunstable, Central Bedfordshire40 GBP/hourMember since July 6, 2023
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quality management specialistpharmaceutical product developmentprocess 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.
