Develop Iso 9001, 22716, 13485, Regulatory, Qms Document

About:

MY BACKGROUND: Registered Pharmacist having more than 8.5 years of working experience in different field of global healthcare Pharmaceutical research organization. Currently managing regulatory, Quality Management Systems, Training and Gap Analysis/Risk Management Systems of the company.

MY SPECIALIZATION:

·ISO 9001:2015, ISO 13485:2016, ISO 14971, ISO 22716, ISO 31000

·USFDA 21CFR Part 4, 111,210,211,700,701,740,820

·21CFR part 11, GAMP 5, EU Annex 11

·EU GMP

·ICH Q7, Q9, Q10

·PIC/S

 

WHAT I CAN DELIVER:

·Support to get ISO approval

·Develop Quality management System

·Risk management

·Regulatory Support

·Feasibility study

·Site Master File as per PIC/S Guideline and Site Validation Master Plan

·Risk based Facility, Utility, Equipment Qualification

·Computer System Validation

·Risk Based Process Validation, Cleaning Validation

·Transport Validation

·SOP preparation, Gap Analysis of cGMP and define action plan

·Training material/plan/report

·Manage Audit as a “Certified Auditor”

·Project Management / Coordination with Clients, Subcontractors and Suppliers

·Preparation of manufacturing and Quality Agreement

Kind Regards,

Taslima

Reviews

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Great personality ,Dedicated and professional. Definitely gonna work with Taslima again

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