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
2022.11 - 2025.06
- 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
2021.01 - 2022.09
- 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
2019.10 - 2020.11
- 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
2019.07 - 2019.09
- Assist customer to provide healthcare advice, non-prescription medication to the consumer.
Intern Pharmacist
Pharmaniaga Manufacturing Berhad
Bangi
2018.05 - 2018.07
- 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
2015.08 - 2019.05
Foundation in Science -
University of Cyberjaya
2018.07 - 2019.05
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
2022.11 - 2025.06
Pharmacist cum Branch Manager
Hoe Pharmaceutical Sdn Bhd
2021.01 - 2022.09
Provisional Registered Pharmacist
Sainuka Habib Sdn Bhd
2019.10 - 2020.11
Pharmacy Assistant
Med constant Pharmacy Sdn Bhd
2019.07 - 2019.09
Foundation in Science -
University of Cyberjaya
2018.07 - 2019.05
Intern Pharmacist
Pharmaniaga Manufacturing Berhad
2018.05 - 2018.07
Bachelor of Pharmacy -
University of Cyberjaya
2015.08 - 2019.05