NOR SHAKIRAH SAUHAMI
Senior Executive
Kuala Kangsar
Summary
Experience analyst with more than 10 years in pharmaceutical industry focusing on analytical method development, troubleshooting for drug substance and product. My dedication to excellence, problem-solving mindset and commitment to continuous learning to make me knowledgeable and valuable asset.
Overview
11
11
years of professional experience
2
2
Certifications
Work History
Senior Executive
Ranbaxy (Malaysia) Sdn. Bhd.
02.2024 - 07.2025
- As Section Head of GLP and Raw Material Section & in-charge in QC lab procurement (Price negotiation, PR issuance - SAP HANA, receiving of materials & invoice clearance).
- Involve in method transfer activity from R&D Centre, India.
- Support in material evaluation (initial quality test) for incoming materials through documentations provided (e.g : COA).
- In-charge in method verification/validation activity for pharmacopeia compliance and regulatory queries.
- Participate in internal, corporate quality audit and regulatory inspections of QC operations.
- Response for the audit observation by implementing through CAPA.
- Experience as an auditee during GMP inspection by NPRA.
- Experience in using Lab Inventory Management System (LIMS), Trackwise and Electronic Data Management System (EDMS) for laboratory management.
- Ensure activities conducted is carried out as per procedure.
- Review analytical report for Method Validation/Verification, Finished Product and Process Validation report.
- Conduct lab investigation related to OOS, OOT, laboratory incidences and deviations.
Executive
Duopharma Innovation Sdn. Bhd.
08.2021 - 02.2024
- Develop and optimize analytical method especially using HPLC/UV-Vis for raw materials (Active Pharmaceutical Ingredients - API), excipients and finished products.
- Handling instruments such as HPLC, FTIR, Dissolution tester and UV-Visible spectrophotometer.
- Conduct comparative dissolution profile in different dissolution media for new product development or formula improvement.
- Familiar with drug substance and drug product such as DRGD, USFDA, EMA, United States Pharmacopeia, British Pharmacopeia, US Pharmacopeia and ICH Guidelines.
- Prepare analytical documents such as analytical test method and specification, Raw Material Evaluation report and Standard Operating Procedure (SOP) for any new equipment or new system to be implemented.
- In-charge in micropipette internal verification & maintenance.
- Implement internal QC check for Karl Fischer Water Content for ISO 17025 purpose.
- Handle procurement for project in-charge by liaise with vendor / supplier in sourcing of chemicals, consumables, reference standard & related equipment to be used in project conducted.
- In-charge of method development of Particle Size Distribution test using Malvern Particle Size Analyzer 3000.
- In-charge in method troubleshooting (especially for Assay and Related Substances) for existing / new product from Duopharma Innovation Sdn. Bhd. (R&D Centre) and subsidiaries (Duopharma Manufacturing site) and correspondence received from Regulatory bodies (such as NPRA).
R&D Chemist
Sunward Pharmaceutical Sdn. Bhd.
11.2019 - 08.2021
- Responsible to source, negotiate and purchase materials or equipment and services from local vendors.
- In charge of purchasing needs such as planning, issuing and following up on Purchase Orders delivery and delivery of the goods including with installation (IQ, OQ) of new equipment.
- Communicate with external parties for testing method enquiry and outsource testing.
- Responsible for testing of new raw materials and finished product for method trial testing through method evaluation test according to pharmacopeia (USP and BP).
- Responsible in implementation of new methodology, procedures and specification for existing raw materials and finished products.
- Prepare Certificate of Analysis (COA) when required.
- Update and liaise with Regulatory Affairs for any correspondence from NPRA (e.g: product complaint from customer).
- Responsible in budget preparation for new R&D project especially for the Analytical site.
Laboratory Officer
Taylor’s University
11.2018 - 11.2019
- Responsible to source, negotiate and purchase materials or equipment and services from local vendors.
- Person in charge in purchase items for School of Pharmacy. (Request for Quotation from few suppliers, issue Purchase Request, email Purchase Order to supplier and follow up for delivery of items).
- In charge of purchasing needs such as planning, issuing and following up on Purchase Orders and delivery of the goods.
- Evaluate supplier performance based on quality standards, delivery time and best price and ensure all criteria met according to requirement and expectation.
- Person in charge and perform maintenance and troubleshooting for HPLC and FTIR.
- Ensure that all equipments in laboratory are calibrated and in good condition before use.
- Keep a record for all consumables and chemicals available in laboratory and keep track for usage.
- Require to demonstrate to student’s proper techniques during practical session as well as assist lecturers.
- In-charge in inventory stock for chemicals and glassware used in pharmacy practical laboratory.
- Perform internal verification for equipment used for practical class.
QC Chemist
Xepa Soul Pattinson (Malaysia) Sdn. Bhd.
01.2018 - 03.2018
- Perform chemical and physical tests on stability study sample, checks and compile test report.
- Perform maintenance and troubleshooting of instruments used.
- Ensure that HPLC, Disintegration tester and UV-Vis are in good condition before used.
- Person in charge in handling working standard and reference standard.
- Write, revise and check documents such Standard Operating Procedures (SOP), Work Instructions and Specification in periodic document review.
R&D Analyst
YSP Industries (M) Sdn. Bhd.
11.2014 - 12.2017
- Conduct dissolution testing when assigned. (Tablet, Capsules)
- Proficient in handling various kinds of High-Performance Liquid Chromatography such as Agilent, Waters and Shimadzu.
- Proficient in using software for HPLC such as Empower (Waters and Agilent), Lab Solutions (Shimadzu)
- Able to handle others equipments such as Ultra Violet- Visible Spectrometry (UV-Vis), Fourier Transform-Infrared Spectrometry (FT-IR), pH meter, Dissolution Tester, Disintegration Tester.
- Conduct stability studies on existing products for local and overseas registration.
- Conduct testing for new sourcing raw materials for existing and new products.
- Person in charge for utilization of High-Performance Liquid Chromatography (HPLC).
- Maintenance of the equipments follow the standard operating procedure (SOP).
- Perform daily calibration of equipments such as pH meter, 4 decimal balance and semi microbalance.
Education
Bachelor of Science (Hons) - Chemistry
Universiti Kebangsaan Malaysia
11.2014
Matriculation - Physical Science
Kolej Matrikulasi Kedah
05.2011
Skills
- Director of Hari Interaksi Kelab Sains Kimia 2013
- Secretary of Senamrobik Club 2010/2011
GLP compliance
Method validation
Quality audits
CAPA implementation
HPLC analysis
Analytical documentation
Project procurement
Analytical method development
Stability studies
Data management
Certification
Introduction to ESG : Environmental Social and Governance
References
- Nik Mohd Zulhakimi, bin Nik Abdullah, Manager II, Analytical Department, zulhakimi@duopharmabiotech.com, 012-5876090, Duopharma Innovation Sdn. Bhd.
- Saidatul Ameera Nabilah, binti Mohd Noor, Senior Executive, Analytical Department, saidatul-ameera@duopharmabiotech.com, 013-3787592, Duopharma Innovation Sdn. Bhd.
- Wong Jun Yong, R&D Pharmacist, junyong797@gmail.com, 013-7766628, Sunward Pharmaceutical Sdn. Bhd.
PERSONAL TRAITS, STRENGTH
- Able to work independently with minimal supervision
- Good in written and spoken for both languages (Bahasa Malaysia and English)
- Familiar with ISO 9001 and ISO 17025.
- Able to work under pressure and long working hours.
JOB PREFERENCES
- Willing to travel : YES
- Posses own transport : YES
Timeline
Senior Executive
Ranbaxy (Malaysia) Sdn. Bhd.
02.2024 - 07.2025
Executive
Duopharma Innovation Sdn. Bhd.
08.2021 - 02.2024
R&D Chemist
Sunward Pharmaceutical Sdn. Bhd.
11.2019 - 08.2021
Laboratory Officer
Taylor’s University
11.2018 - 11.2019
QC Chemist
Xepa Soul Pattinson (Malaysia) Sdn. Bhd.
01.2018 - 03.2018
R&D Analyst
YSP Industries (M) Sdn. Bhd.
11.2014 - 12.2017
Matriculation - Physical Science
Kolej Matrikulasi Kedah
Bachelor of Science (Hons) - Chemistry
Universiti Kebangsaan Malaysia