Summary
Overview
Work history
Education
Skills
Certification
Projects
Timeline
Generic
Nooraisha Abdul Guthoos

Nooraisha Abdul Guthoos

Kajang,Malaysia

Summary

Registered Pharmacist with over 4 years of experience in pharmaceutical production and regulatory compliance. Proven track record in managing cGMP-compliant operations, handling audits, preparing regulatory documentation, and cross-functional collaboration. Seeking to transition into Regulatory Affairs to contribute technical expertise and regulatory knowledge towards successful product registration in local and international markets.

Overview

7
7
years of professional experience
5
5
years of post-secondary education
1
1
Certification

Work history

Production Executive cum Pharmacist

Hoe Pharmaceutical Sdn Bhd
Port Klang, Malaysia
11.2022 - 06.2025
  • Oversee production activities to ensure compliance with cGMP and timely delivery of products.
  • Led preparation and updates of SOPs, BMR/BPRs, and logbooks according to regulatory requirements.
  • Managed deviations, CAPA, and implemented change control procedures.
  • Participated in internal/external audits (EFDA, NPRA, Safety, Pharmacy Enforcement) with successfully passed the audit with minimal findings. Address the audit findings and close the findings promptly.
  • Collaborated with Engineering, QA and Technical Service for validation, hold-time studies, and technical troubleshooting.
  • Maintain the Pharmacist’s Poisons License (Type A-License), Poison Signed Order and all statutory requirements.
  • Troubleshooting of production problems, responsible for handling deviation, CAPA with Root Cause Analysis (RCA) and coming up with change control within production.
  • Conduct safety awareness & enforce safety regulations in production.
  • Evaluate the production records and ensure that they are signed by an authorised person before they are sent to the Quality Department.
  • Communicate and coordinate with Enforcement officers and inspectors on regulatory requirements.


Pharmacist cum Branch Manager

Hoe Pharmaceutical Sdn Bhd
Jeram
01.2021 - 09.2022
  • Manage pharmacy operations following ISO 9001:2015 standards to achieve profitability and turnover targets.
  • Provide excellent service and maintain good relationships with customers.
  • Provide basic health screenings, counsel and advise clients on their medication regimen to improve health conditions.
  • Manage the inventory -ordering & return of goods to ensure smooth operation of the pharmacy.
  • Record poison accurately and address poison-related issues.
  • Stay updated on market trends and inspire the team to meet goals.


Provisional Registered Pharmacist

Sainuka Habib Sdn Bhd
Bangi
10.2019 - 11.2020
  • Ensured compliance with poison act documentation and inventory control.
  • Assist customer to provide general healthcare advice and supply prescription and non - prescription medication.
  • Record poison accurately and address poison-related issues.

Pharmacy Assistant

Med constant Pharmacy Sdn Bhd
Puchong
07.2019 - 09.2019
  • Assist customer to provide healthcare advice, non-prescription medication to the consumer.

Intern Pharmacist

Pharmaniaga Manufacturing Berhad
Bangi
05.2018 - 07.2018
  • Attached at Production department to observe all the processing and take note the monitoring parameters during the production is done.
  • Attached at QA, QC, Engineering and Technical department for Exposure and understood the big picture of the Drug Production.
  • Completed Log Book as required by the course.
  • Done a mini project regarding the operation of Pharmaceutical Company.

Education

Bachelor of Pharmacy -

University of Cyberjaya
08.2015 - 05.2019

Foundation in Science -

University of Cyberjaya
07.2018 - 05.2019

Skills

  • Regulatory Documentation & Compliance
  • cGMP, GDP, ISO 9001:2015
  • SOP & Technical File Preparation
  • Audit Preparation & CAPA
  • Root Cause Analysis (RCA)
  • Interdepartmental Coordination
  • Training & Staff Development
  • Bahasa Malaysia, English, Tamil – Fluent

Certification

  • FMM Professional Certificate in Supervisory and Coaching, FMM Institute, Apr 2024
  • GMP- Essentials, Malaysian Organisation Of Pharmaceutical Industries, Jan 2024

Projects

Thesis Writing, Research title: The Exploratory Study on Halal Built-in Management System for Halal Pharmaceutical based on Industrial Perspective., A Qualitative study is conducted by mapping current references and guidelines (MS 2424) with the output from Halal Pharmaceutical Expert by doing focus group discussion.

Timeline

Production Executive cum Pharmacist

Hoe Pharmaceutical Sdn Bhd
11.2022 - 06.2025

Pharmacist cum Branch Manager

Hoe Pharmaceutical Sdn Bhd
01.2021 - 09.2022

Provisional Registered Pharmacist

Sainuka Habib Sdn Bhd
10.2019 - 11.2020

Pharmacy Assistant

Med constant Pharmacy Sdn Bhd
07.2019 - 09.2019

Foundation in Science -

University of Cyberjaya
07.2018 - 05.2019

Intern Pharmacist

Pharmaniaga Manufacturing Berhad
05.2018 - 07.2018

Bachelor of Pharmacy -

University of Cyberjaya
08.2015 - 05.2019

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Nooraisha Abdul Guthoos