Jivashny Chandran
Regulatory Affairs
Rawang
Summary
Resourceful Regulatory Affairs Associate with 1 year of extensive experience in ensuring that company products meet regulatory regulations. Improved processes and assisted product development in meeting regulatory requirements. Assist in renewal and maintenance of Product Registration Licenses. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Associate
GlaxoSmithKline
5 2023 - Current
- To assist regulatory staff in renewal and maintenance of Product Registration Licenses in Malaysia and Brunei via a Third-Party Agent.
- To assist regulatory staff for Life-Cycle Management of all registered products in Malaysia and Brunei such as PI/PIL update, Artwork Changes, CMC Changes, Change of Sites, New Indications and Dosages Variations and all other changes that affect the registered information within Regulatory Authorities in Malaysia and Brunei.
- To assist regulatory staff for all matters pertaining to the registered products including archiving in Regulatory Vault and retention of the product files.
- To ensure the created and approved Artworks for Market specific Pack (MSP), Shared Pack, Multi Market Pack, General Export Pack (GEP) and all other Supplied artworks are compliance with relevant national, regional and global labelling requirements.
- Involve in Vaccine Lot Release (VLR) documentation and VLR payment preparation.
- Communicates with cross functional department and stakeholders regarding work matters.
Quality Control Assistant
Bio Harvest Sdn Bhd
10.2022 - 05.2023
- Supported the unit head in ensuring the department is running efficiently.
- Carried out Quality Control tasks in accordance with the policies, procedures and guidelines on a timely and accurate manner.
- Observed and monitored production operations and equipment to ensure conformance to specifications.
- Educated the production team about the quality control concerns and GMP procedures.
- Involved in verifying Artworks for labels and product boxes of products.
- Involved in preparation of Certificate of Analysis (CoA) for all products that being manufactured.
- Carried out microbiological tests on the manufactured products.
Malaysian Psoriasis Registry Manager
Hospital Kuala Lumpur (HKL)
08.2022 - 08.2022
- Registered the details of patients affected with psoriasis and analyzed those data using IBM SPSS software.
- Needed to send the registry forms to all the respective hospitals and centers.
Call Centre Agent
Transcosmos (M) Sdn Bhd
04.2022 - 06.2022
- Verified applications of customers in loan approval.
Clinical Laboratory Assistant
BP Healthcare Goup
10.2020 - 01.2021
- Carried out the various clinical tests using the blood serum, blood, urine and stool samples.
- Involved in collecting samples, arranged and distributed them.
- Prepared buffer solution for analyzing machines to carry out the tests.
- Learnt on how to carry out the clinical tests in both automatic and manual procedures.
- Learnt on proper ways of handling those hazardous biological samples.
Quality Checking (QC)
Thermik Technologies Sdn Bhd
01.2018 - 04.2018
- Performed final checking of the wires and electronic components before exporting.
- Making recommendations for improvements where necessary.
English Tutor
Kumon Education Group
12.2015 - 04.2016
- Collaborated with students to complete homework assignments, identify lagging skills and correct weaknesses.
- Improved students' written and verbal English skills through personalized learning programs.
- Enhanced students' reading and writing and listening skills by implementing interactive and engaging lesson plans.
Education
Bachelor of Science (Honours) Biotechnology -
Universiti Tunku Abdul Rahman (UTAR)
Kampar, Perak, Malaysia03.2022
Skills
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Microsoft Office (Word, Excel, Powerpoint, Power BI and Microsoft Outlook)
Regulatory & Artwork Softwares (Regulatory Vault, Veeva Vault, GLAMS)
Good written and oral communication skills
Product Labeling
Compliance assurance
Regulatory Submissions
Quality Management Systems
Certification
Basic Statistic Workshop - Clinical Research Centre Hospital Kuala Lumpur, 09/2022
Languages
Tamil
Native language
English Language
Proficient
C2
Malay Language
Proficient
C2
French
Elementary
A2
Awards
- Dean's List Award - Universiti Tunku Abdul Rahman, 10/2019, GPA 3.67
- Adventure Badge (Lencana Pengembaraan) - Persatuan Pengakap Malaysia Daerah Hulu Selangor, 09/2017, Participated hiking activities to the peak of Gunung Berembun, Cameron Highlands, Pahang
- Volleyball Championship MSSD Hulu Selangor (Kejohanan Bola Tampar MSSD Hulu Selangor) - Majlis Sukan Sekolah-Sekolah Selangor Daerah Hulu Selangor, 04/2010, Participated in the volleyball championship during school days.
Timeline
Quality Control Assistant
Bio Harvest Sdn Bhd
10.2022 - 05.2023
Malaysian Psoriasis Registry Manager
Hospital Kuala Lumpur (HKL)
08.2022 - 08.2022
Call Centre Agent
Transcosmos (M) Sdn Bhd
04.2022 - 06.2022
Clinical Laboratory Assistant
BP Healthcare Goup
10.2020 - 01.2021
Quality Checking (QC)
Thermik Technologies Sdn Bhd
01.2018 - 04.2018
English Tutor
Kumon Education Group
12.2015 - 04.2016
Regulatory Affairs Associate
GlaxoSmithKline
5 2023 - Current
Bachelor of Science (Honours) Biotechnology -
Universiti Tunku Abdul Rahman (UTAR)
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