Azura Methar Shah
Abu Dhabi
Summary
Experienced in the pharmaceutical industry, dedicated professional consistently meeting company goals through organized and consistent practices. Thriving under pressure, excel at adapting to new situations and challenges, always striving to enhance the organizational brand. Confident in the ability to contribute to the growth and success of any team or organization within the industry.
Overview
4
4
years of professional experience
Work History
EXECUTIVE
NOVUGEN PHARMA SDN BHD
01.2023 - Current
- Plan and develop systems and procedures to improve the operating quality and efficiency of the Production Department
- Responsible to prepare new Batch Manufacturing and Packing Record (BMR and BPR) as requested
- Responsible in dealing with regulatory queries/correspondence for product approval
- Responsible to prepare supporting document required for regulatory submission
- To ensure all manufacturing batches are produced in accordance with the standard operating procedures and consistently meeting the cGMP requirements and product specification
- Responsible to review the executed BMR and BPR as requested
- Responsible to perform and prepare OOS/OOT investigation report
- Responsible in monitoring QMS completion such as deviation, change control, CAPA etc
- In production
- Responsible to ensure that the required products are being produced according to the pre-determined quality specifications and being delivered on time through cost effective production planning strictly compliance to cGMP regulations
- Responsible to verify dispensing activity and the quantity of dispensed material
- Responsible to coordinate the calibration activity in production
- Responsible to ensure that all SOPs are reviewed according to schedule and amended whenever necessary
- Boosted team productivity by providing comprehensive training, mentorship, and performance evaluations.
- Supervise and monitor activities of all cleaners in production area
- To provide support and assist during regulatory inspection by regulatory authority
- To support production leadership and support for continuing process improvement efforts for manufacturing which benefit the line quality, efficiency and/or productivity
- To address the gaps of non-compliances or production issue; recommend actions to ensure gap or issue is closed within agreed budgets and time frame
- To ensure that all production activities are accurately described in written procedures or instructions and meet cGMP requirements
- Perform other related duties as assigned from time to time based on company needs.
- Managed to prepare 6 -7 BMRs within 3 days which consists of 250 to 300 pages each for product execution, which helps to manufacture the product and send it to the market in timely manner.
ASSOCIATE EXECUTIVE
NOVUGEN PHARMA SDN BHD
09.2021 - 12.2022
- Responsible to develop, improve and provide good practice in relation to Current Good Manufacturing Practices
- Spearheaded in preparing documents related like Batch Manufacturing Records and Batch Packing Records for regulatory submissions
- Ensure that the required products are being produced according to the predetermined quality specifications and being delivered on time through cost effective production planning strictly compliance to cGMP regulations.
- Able to complete any urgent tasks within one day based on the priority.
- Managed to prepare over 10 BMRs in a week for product execution.
PROTÉGÉ TRAINEE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
11.2020 - 08.2021
- Participated in all laboratory testing for raw material and finished products including in process quality control testing and documentations.
- Managed to complete at least 3 - 6 batches of product testing per day where able to release the batches to the market on time.
INTERNSHIP
MALAYSIAN VACCINE AND PHARMACEUTICALS SDN BHD
10.2019 - 01.2020
- Participated in producing inactivated veterinary vaccines using virus.
- Responsible for egg fumigation, Incubation of eggs, candling and marking eggs to discard infertile and dead eggs.
- Responsible in disinfecting eggs with iodine and prepare theeggs for inoculation of ND Lasota Virus.
- Responsible for harvesting the eggs to collect the allantoic fluid by suction using needle.
- Responsible for inactivation of the bulk virus collected using 2-Bromoetylamine hydrobromide.
- Responsible in filling of inactivated oil adjuvant ND vaccine into sterile bottles and proceed it for capping, labelling, packing and store in cool room.
- Managed to produce inactivated vaccine using 1000+ eggs in a week as the process will take around 2 weeks to complete.
Education
Bachelor of Pharmaceutical Science with Health Sciences (Hons) - Pharmaceutical Sciences
KPJ Healthcare University
Nilai, Negeri Sembilan 09.2020
Foundation in Science - Science
Manipal International University
Nilai, Negeri Sembilan 04.2016
Skills
- Excellent in Computer skills and formulation skills
- Able to conduct IPQC tests, able to operate UV spectroscopy, IR spectroscopy, HPLC, GC, Dissolution machine, Disintegration machine, Karl Fischer, Auto titrator, ICP and also excellent in conducting other laboratory experiments including microbiological testing
- Excellent in aseptic technique, virus cultivation including bacteria and fungus, good in media preparation, and excellent in handling microscope
- Good in operating SAP
- Good interpersonal and communication skill
- Good analytical and initiatives as well as creative thinking
- Able to work independently
- Team Leadership
- Quality Management
- Problem Resolution
- Experienced in conducting audit
- Staff Training
Accomplishments
- Organized and participated in Mental Health Awareness program.
- Organized Tea party with pharmaceutical companies
- Participated in Sport First Aid and CPR training.
- Participated in Wet Granulation Tablet Manufacturing workshop.
- Achieved highest GPA 4.00
- Achieved Certificate of Merit (High Achiever's Award) For Research Project In Pharmaceutical or Health Sciences With Distinction of 90.00 Marks
- Participated in NPRA audit and successfully passed the audit with zero observations.
- Attended training for USFDA with QUALIMINDS CONSULTANCY.
- Participated in USFDA Audit and successfully passed the audit with three minor observations.
- Participated in Taming Tableting training.
Languages
English
Upper intermediate (B2)
Tamil
Advanced (C1)
Malay
Advanced (C1)
Personal Information
Marital Status: Single
Driving License: D (Malaysian Car Driving License)
References
Noresnita Salleh, Assistant Manager, Production, Novugen Pharma Sdn. Bhd (+60 122926475)
Work Preference
Work Type
Full TimeWork Location
RemoteOn-SiteHybridImportant To Me
Company CultureWork-life balanceCareer advancementPaid sick leaveHealthcare benefitsFlexible work hoursTeam Building / Company RetreatsPersonal development programs4-day work weekWork from home optionTimeline
EXECUTIVE
NOVUGEN PHARMA SDN BHD
01.2023 - Current
ASSOCIATE EXECUTIVE
NOVUGEN PHARMA SDN BHD
09.2021 - 12.2022
PROTÉGÉ TRAINEE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
11.2020 - 08.2021
INTERNSHIP
MALAYSIAN VACCINE AND PHARMACEUTICALS SDN BHD
10.2019 - 01.2020
Bachelor of Pharmaceutical Science with Health Sciences (Hons) - Pharmaceutical Sciences
KPJ Healthcare University
Foundation in Science - Science
Manipal International University
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