プロフィール詳細

プロジェクトを作成

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Sindhu K.に依頼

Canada

Specialized as GMP Coordinator, QA & Regulatory Professional; have over 18+ years of experience

プロフィール概要

EXPERTISE  18+ years of experience working with companies across Asia, Australia and Canada  Quality Assurance, Compliance & GMP Coordination o Prepare and Conduct Internal & External Audits such as Supplier Audits, GMP Audit, Social & Security Audit, 3rd Party Audits, Pre-Licensing Inspections o Develop, Revise and Maintain Quality & Technical Documents such as SOPs, QAR, GMP Guidance Document o Assessment and GAP Analysis of Facility Compliance o Develop, Implement and Improve existing QMS - Optimization of Process Flow, CAPA, Deviation Protocol, OOS Reporting, Batch Record Review, Change Control, Product Recall Procedure, Cleaning & Sanitization Protocol, Preventative Maintenance Protocol, Supplier Qualification Protocol, Emergency Preparedness etc. o GMP Coordination in compliance to standards of US FDA, Health Canada & EU  Quantitative and Qualitative Market Research Studies including Focus Groups o Medical Market Research; Consumer Product Goods Industry; Service Orientated Industries  Provide Regulatory, QA and Compliance Support during Product Development and Formulation o Develop Preventative Control Plan, Storage and Safe Handling of Chemicals, Food Safety Protocol o Evaluation of QA, Compliance and Regulatory needs leading to scale-up of the existing operations o Optimize Process Protocols including development of People and Process Flow Chart  Regulatory Affairs Support: Develop and Submission of various regulatory documents but not limited to… o Site & Establishment License o Cosmetic Notifications o Cannabis License Application o SPL Product Listing, DUN#, NDC#, NPN, DIN, CNF  Technology Focused Support o Design, Engineer & Manufacture Products with Embedded Technology o Plan, Design and Implement Agricultural / Industrial Automation o Software designed Data & Analytics Current Projects 1) QAP on record for a company specialized in manufacturing cannabis edibles 2) Regulatory Advisor - Prepare and Submit DIN-D Application for Disinfectant Product 3) Regulatory Advisor - Prepare and Submit CTA and Exemption for Subsection 56(1) of CDSA 4) Project Management, Regulatory & QA Advisor - Manage submission of Cannabis License Application for Cultivation, Nursery and Medical Sales 5) Market Research - Recruit Endocrinologist and Oncologist for a Study on management of GEP-NET / Acromegaly

専門分野

• ★ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Research

サービス

• Writing
• Research
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis, Data Visualization

Product Development Formulation

職務経験

Independent Consultant / Founder

Cindia Pro Inc

8月 2010 - 現在

学歴

Bachelor in Pharmacy

JSS College of Pharmacy

10月 1995 - 10月 1999

認定資格

• Certificate in Medical Cannabis GMP

  Pharmout

  8月 2020 - 8月 2020

• Diploma: Professional Regulatory Affairs

  Academy of Applied Pharmaceutical Sciences

  1月 2009 - 10月 2009

• Certificate: Quality Assurance for Medical Marihuana from Academy of Applied Pharmaceutical Sciences

  Academy of Applied Pharmaceutical Sciences

  8月 2009 - 8月 2009

• Certificate Course in Venipuncture

  Adept Training Pty Ltd

  6月 2004 - 7月 2004

• Diploma in Pharmacy

  JSS College of Pharmacy

  6月 1993 - 10月 1995