Navadon Tatiyawattanachai

Currently Responsible for.

1. Part of Validation Team for Electronic batch record.

2. Responsible person for Change Control personnel for Manufacturing Process of Beta-Lactam Drug Products and Others Change that doesn't fitted in to categories.

3. Batch release and Product Quality Review

4. Coach Material Problem Management personnel.

5. Give a guidance for Deviation Management personnel and responsible person for Change Control Primary package.

6. Develop and Update Section's Documents such as work instructions, related form, etc.

7. Internal Logbook data (Excel) Cleaning and Analysis.

8. Assisted in Internal management, Performance review and Tasks/Responsibilities management.

9. Phasing in as Electronic change management Team personnel.

Jan 2025

• Revise All related report form (Excel) used in routine section's works to be complied with OneDrive format.
• Re-initiated the periodic review process of each section's works for improvement.
• Phasing in as Electronic change management Team personnel. (responsible for verification of change details of data in SAP)

Jun - Dec 2024

• Be a part of a Development and Validation Team for Electronic batch record.
• Developed and Updated policies and procedures to maintain a compliance with the Electronic batch record and Guidelines relating to GMDP and ISO 9001.
• Be a part of Risk Assessment Team for normal process of Penicillin's production line.
• Phasing out from Material Problem Management Team.
• Coach the next responsible person for Material Problem Management (new recruited).
• Plan and Delegate Responsibilities for Product Quality Review 2025. Also, Revise the Product Quality Review protocol to improve the process of data filling.
• Optimized section's Training plan for 2025.

Mar - May 2024

• Be a Trainer for Change Control Management per annual training plan.
• Be a part of Internal Auditor Team 2024
• Lead Auditor of Supplier Audit 2024 for Primary packaging.
• Suggest Updates and Enhancements to Work Instructions and Standard Operating Procedures.

Dec 2023 - Feb 2024

• Phasing in as Change Control personnel for Manufacturing Process of Beta-Lactam Drug Products and Others Change that doesn't fitted in to categories. For Example. Change of Product related Artwork.
• Coach the planned next responsible person for Change Control Primary package.
• Developed new targets and performance Indicators (OKR&KPIs) to enhance Change Control Management.
• Plan and Delegate Responsibilities for Product Quality Review 2024.
• Survey Feedback of Logbook (Excel) and Related Form for Deviation, Material Problem, Customer Complaint and Change Control for improvement.

Nov 2023

• Focused on Batch Release for Annual closing.

Oct 2023

• Secretary of Directors Meeting of the Month.

May - Sep 2023

• Phasing out from Deviation Management Team.
• Train and Monitor new recruited personnel for Batch release and Deviation Management.
• Be a Trainer for Deviation Management per annual training plan.
• Revise Material Problem Management Workflow.
• Revise Material Problem Management KPIs and Related Documents.
• Re-Initiate Section's Knowledge Sharing Session.
• Be a Part of Internal Auditor Team 2023
• A representative of QA for testing and qualification for Electronic Batch Record.

Mar - Apr 2023

• Phasing in as Material Problem Management Personnel (Manage Non-conforming Raw Material and Packaging Material).
• Phasing in as Change Control Management Personnel for Primary Packages.
• Material Problem Data Cleansing and Analyze (Excel).
• Review of Deviation Management 2022.
• Review of Material Problem Management 2022

Jan - Feb 2023

• Proposed and Manage Initial Change of Section's Structure.
• Delegate and Coach QA Team to Manage Batch Release Workload.

Nov - Dec 2022

• Review of Production's Risk Assessment.
• Product Quality Review

Oct 2022

• Revise Deviation Management Workflow and Re-Training Deviation Management Team.
• Revise Deviation Management Section's OKRs&KPIs and Related Documents.
• Change the way of approach for Product Quality Review.

Jul - Sep 2022 (End of probationary period)

• Coordinated with Business Planning Department and Manage Workload of Batch Release.
• Deviation Data Cleansing and Analyze (Excel).
• In-Training for Section's Responsibilities.

Jun 2022

• Registered as one of Responsible Person for Release Products.
• Responsible as one of Deviation Management Personnel.

May 2022

• In-Training for Release Products and Deviation Management.
• Batch Record Data Cleansing and Analyze (Excel).

Consultant for the Founder

• Drugs and Disease Counseling Services.
• Observe the Counseling Services and Feedback for Improvement.
• Monitor Inventory.

• Drugs and Disease Counseling Services

Intern at Quality Assurance Department (Feb - Apr 2022)

• In-Training for Basics of QA's role for Pharmaceutical Quality System.
• Product Quality Review.
• Mock Product Recall.
• Be a part of Internal Auditing Team.
• QA-In-Line Production Inspection.
• Presentation of Lean-SixSigma and Process Capabilities.
• Train Basic of Program:Minitab for Scientists in Production Department.

Intern at Regulatory Affairs Department (Oct 2021 - Feb 2022)

(Mainly Work Form Home)

• Review of GMP/PICS PE 009-16 Compared to PE 009-15.
• Review of Thailand's Regulation for Narcotics Drugs.
• Review of GMP for Medical Devices.
• Review of Thailand's GDP Compared to EU GDP.
• Presentation of Reviewed Subjects.

Intern at Quality Control Department (May - Oct 2021)

• In-Training for Chemical and Microbial Tests.
• Create and Validate Microsoft Excel for Stability Study.
• Presentation of Computerized System Validation.
• Intern Team's Presentation of Theory of Analytical Method Validation.