Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
BusinessDevelopmentManager
NOR FARIZAN MOHD NOR

NOR FARIZAN MOHD NOR

SENIOR QA EXECUTIVE
Shah Alam

Summary

Dedicated and detail-oriented person with more than 10 years experience in pharmaceutical manufacturing industry.

Experienced with quality assurance methodologies and best practices. Utilizes attention to detail and analytical skills to identify and resolve defects effectively. Knowledge of team collaboration and strategic problem-solving, poised to thrive in quality-focused role. Eager to learning and develop in dynamic environment.

Overview

11
11
years of professional experience
4
4
years of post-secondary education
2
2
Languages

Work History

Senior QA Executive

Bio-Angle Vacs Sdn. Bhd.
Serdang
07.2023 - Current
  • Responsible for the routine operational and compliance functions, from raw material handling to product release, including production oversight, handling of product recall/ complaints, handling of deviations, corrective actions and preventive actions (CAPA) and quality audits.
  • Plan and lead routine operation and GMP compliance functions. Manage document control and production change control.
  • Lead and manage product release procedures, including review of Batch Manufacturing Records (BMR) to ensure products and processes meets the predetermined specification and compliance to current Good Manufacturing Practices (cGMP) guideline.
  • Responsible as the Secondary Person for conducting final product batch release and providing decision for product recall.
  • Lead and manage the company's Quality Management System (QMS), that includes Quality Risk Management and annual Product Quality Review.
  • Quality Risk Management - Coordinator for Risk Management that been raised by other departments. Lead team to conduct risk assessment to identify and mitigate potential quality issues.
  • Lead Auditor / Auditor/ Coordinator and auditee during internal and external audit for audit (DVS). Conduct Internal Audit for GMP and external supplier audit.
  • Trainer for GMP and other applicable guidelines/ standards. To give training and briefing of the needs of GMP to new employee and existing employee as refreshment.
  • Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
  • Project manager for ZEPA products for Malaysia market. Function to monitor all the progress and timeline of the activities such as registration, marketing, business development, field trial and events.

Quality Assurance Executive

Pharmaniaga Manufacturing Berhad
Bandar Baru Bangi, Selangor
01.2014 - 07.2023
  • Company Overview: Bdr. Baru Bangi

Year: 2019 - 2023

  • Responsible for checking and releasing Batch Manufacturing Records to market and monitoring of production activities. Complies with current Good Manufacturing Practices and ISO 9001:2015, EHS, OHSAS etc. Justification for product release with investigation.
  • Quality Risk Management - Coordinator for Risk Management that been raised by other departments. Lead team to discuss regarding the risk management of product that related with NDMA issue and prepare the report that need to submit to Regulatory Affair.
  • Review artwork and printing proof.
  • Coordinator/ Auditor and auditee during internal and external audit for audit (NPRA, SIRIM, OHSAS).
  • Coordinator/ Auditor and auditee during Halal Audit.
  • Trainer for ISO 9001 and GMP. To give training and briefing of the needs of ISO 9001:2015 and GMP to new employee and existing employee as refreshment.
  • Subject Matter Expert for SAP system and TrackWise system - Undergo system implementation including requirement study and also testing.
  • Conduct Internal Audit for GMP and ISO 9001:2015.
  • Evaluated audit findings to implement appropriate corrective actions.

Year 2014 - 2018

  • Handling Deviation, Investigation Report and Change Control.
  • Supplier Management -Handling New Sample Evaluation for Raw Materials, Packaging Materials and Miscellaneous. Conduct Customer Satisfaction Survey.
  • Batch Record Checking.
  • Review artwork and printing proof.
  • Preparation and maintenance of Quality Manual for ISO9001.
  • Coordinator and auditee during internal and external audit for audit (NPRA, SIRIM, OHSAS).
  • Trainer for ISO 9001. To give training and briefing of the needs of ISO 9001:2015 to new employee and existing employee as refreshment.
  • Subject Matter Expert for SAP system and TrackWise system - Undergo system implementation including requirement study and also testing.
  • Conduct Internal Audit for GMP and ISO 9001:2015.
  • Trained employees in best practices for quality assurance, fostering a culture of continuous improvement throughout the organization.

Education

Bachelor - Biomedical Science (Honours)

Management & Science University (MSU)
SHAH ALAM
06.2007 - 09.2011

Skills

GMP Auditor /Lead Auditor

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Accomplishments

  • 2024 - Project Manager for ZEPA products for Malaysia market, Uganda, Nigeria, India, China. Achieved 70% registration completed documents compiled for Malaysia market before NPRA submission.
  • 2023 - Establish Quality Management System (QMS) within 6 months (July 2023 - Dec 2023) by completing established all the SOP, forms, internal audit and trainings to other departments.
  • 2022 - Professional Internal Halal Auditor Training by UNITI.
  • 2022 - Speaker with topic 'Audit Management' to USIM students.
  • 2021 - Online webinar: Risk Assessment of N-Nitrosamine in Medical Products.
  • 2020 - External Training (MOPI Training): Risk Management - Quality System and Process.

Timeline

Senior QA Executive

Bio-Angle Vacs Sdn. Bhd.
07.2023 - Current

Quality Assurance Executive

Pharmaniaga Manufacturing Berhad
01.2014 - 07.2023

Bachelor - Biomedical Science (Honours)

Management & Science University (MSU)
06.2007 - 09.2011
NOR FARIZAN MOHD NORSENIOR QA EXECUTIVE