SITI NAZIRAH BT ISMAIL
SUNGAI PETANI
Summary
Experienced Process Engineer with a background as a Validation Officer and QC Chemist. Proficient in technical documentation and data analysis. Committed to self-improvement and excellence in every task. Independent, bold, and driven by a thirst for knowledge. Seeking a mutually beneficial opportunity to contribute to a dynamic company.
Overview
5
5
years of professional experience
1
1
Certification
Work History
PROCESS ENGINEER
STRAITS ORTHOPAEDICS MFG SDN BHD
06.2022 - Current
- Responsible for revising and updating all related technical documents, called Device Manufacturing Records (DMR), for existing and NPI products.
- Responsible for updating the BOM for NPI products as per the customer requirements and standards.
- Skillful in planning and managing to ensure all technical documents are up to date two months ahead based on the forecast or the POs.
- Answering all NCRs, deviations, audit findings, and customer complaints received with effective corrective actions.
- Communicate interdepartmentally to discuss the process improvement and to optimize product yield.
- Developed related work instructions, standard operating procedures (SOPs), PFMEA, and trained staff on best practices.
- Proficient in Microsoft Excel and Microsoft Word, along with a fundamental understanding of other technical software, such as SolidWorks and the MES Epicor System.
VALIDATION OFFICER
ASPEN GLOVE SDN BHD
03.2021 - 06.2022
- Validate the production line by closely monitoring process parameters throughout the production cycle
- Oversee the production line, In-Process Quality Control (IPQC), and QC laboratory parameters and results using Statistical Process Control (SPC)
- Establish optimal control limits and assess process capabilities for each parameter
- Facilitate effective communication across departments
- Execute validations for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Support calibration activities and ensure updates in the SAP system
QC CHEMIST
ZONTRON PHARMACEUTICAL SDN BHD(TERAPEUTIC SDN BHD)
08.2020 - 02.2021
- Responsible for monitoring stability testing for all products
- Oversee process validation for product assessments
- Conduct testing on raw materials, packaging materials, and finished products
- Manage monthly safety monitoring activities
- Coordinate and schedule the calibration of analytical equipment, including furnaces, vacuum ovens, FTIR, analytical balances, HPLC, GC, polarimeters, auto titrators, and others
MANAGEMENT TRAINEES (PROTÉGÉ PROGRAM)
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN BHD (MPI)
11.2019 - 08.2020
- In charge in performing all documentations related to production such as Product Quality Review (PQR), SOP revised and other daily, monthly and yearly monitoring records
- Assisting production related documents for validation purposes
- Revise products literature and label for NPRA approval
Education
Bachelor of Science - Bachelor of Bioprocess Engineering (with Honours)
Universiti Malaysia Perlis
Perlis, Malaysia11.2019
Associate of Science - Foundation in Pure Science
Kolej Matrikulasi Melaka
Melaka, Malaysia06.2015
SPM in Pure Science
SMK Kota Kuala Muda
Kedah, Malaysia12.2013
Skills
- Microsoft Skills
- Documents and reports
- Plan and management skills
- Analytical and Statistical Analysis
- Process validation
- Laboratory skills
- Project management
- Statistical process control
- Design of experiments
- Process development
- ISO 9001 compliance
- Hazardous materials handling
- Cross-functional teamwork
Certificates And Training
- ISO9001:2015 & ISO13485:2016 Internal Audit Training
- ISO17025:2017 & Risk-Based Thinking
- Statistical Process Control (SPC)
- Good Manufacturing Practice (GMP)
- SAP system training
- GD&T Training
Accomplishments
- Silver Awards for Final Year Project(FYP)
- Residential College Committee
- Dean's award Semester 1&2
- Best students for SPM 2013
Certification
- ISO 9001:2015 & ISO 13485:2016 A Process-Approach to Risk-Based Internal Auditing Training.
- Basic HIRARC Certificates
- Attended GMP Training
- Attended GD&T Training
- Attended HALAL training
Languages
Malay
First Language
English
Advanced (C1)
C1
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Work Preference
Work Type
Full TimeWork Location
RemoteOn-SiteHybridImportant To Me
Work-life balanceCompany CultureFlexible work hoursWork from home optionQuote
Every problem is a gift—without problems we would not grow.
Tony Robbins
Timeline
PROCESS ENGINEER
STRAITS ORTHOPAEDICS MFG SDN BHD
06.2022 - Current
VALIDATION OFFICER
ASPEN GLOVE SDN BHD
03.2021 - 06.2022
QC CHEMIST
ZONTRON PHARMACEUTICAL SDN BHD(TERAPEUTIC SDN BHD)
08.2020 - 02.2021
MANAGEMENT TRAINEES (PROTÉGÉ PROGRAM)
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN BHD (MPI)
11.2019 - 08.2020
Bachelor of Science - Bachelor of Bioprocess Engineering (with Honours)
Universiti Malaysia Perlis
Associate of Science - Foundation in Pure Science
Kolej Matrikulasi Melaka
SPM in Pure Science
SMK Kota Kuala Muda
Similar Profiles
MUHAMMAD FARIS IKMAL BIN MOHAMMAD OSMANMUHAMMAD FARIS IKMAL BIN MOHAMMAD OSMAN
QUALITY TECHNICIAN at STRAITS ORTHOPAEDICS (MFG) SDN. BHD.QUALITY TECHNICIAN at STRAITS ORTHOPAEDICS (MFG) SDN. BHD.
THAMARAISELVAN. RTHAMARAISELVAN. R
CNC WIRE EDM Machinist at Straits Orthopaedics (Mfg) Sdn. BhdCNC WIRE EDM Machinist at Straits Orthopaedics (Mfg) Sdn. Bhd
Nicole WongNicole Wong
Assistant Account Administrator at NETWORK STRAITS LOGISTICS SDN. BHD. (MALAYSIA)Assistant Account Administrator at NETWORK STRAITS LOGISTICS SDN. BHD. (MALAYSIA)