Sajetra Vadiveloo Email & Phone Number

Pelabuhan Klang, Selangor, Malaysia

Skudai, Johore, Malaysia

Project in collaboration with Singapore Agrotechnologies Pte Ltd- Conducted research and development on the extraction of Spirulina from five different samples, utilizing high-pressure homogenization and ultrasonication techniques.- Successfully optimized the extraction process for Spirulina, enhancing yield and quality.- Developed and documented comprehensive SOPs for: a) Preparation of 10% w/v Spirulina: Established precise guidelines for the consistent preparation of… Show more Project in collaboration with Singapore Agrotechnologies Pte Ltd- Conducted research and development on the extraction of Spirulina from five different samples, utilizing high-pressure homogenization and ultrasonication techniques.- Successfully optimized the extraction process for Spirulina, enhancing yield and quality.- Developed and documented comprehensive SOPs for: a) Preparation of 10% w/v Spirulina: Established precise guidelines for the consistent preparation of Spirulina solutions. b) Stability Testing: Developed protocols to evaluate the stability of Spirulina extracts over time under various storage conditions. c) Microbial Spoilage Testing: Formulated testing procedures to assess the shelf-life of the spirulina extracts. Show less

Johore, Malaysia

In-Process Optimization & Control:- Monitored process control parameters for downstream operations such as RP-HPLC, crystallizer, centrifuge and lyophilizer.- Executed CIP and SIP for process tanks and 􀏐filtration skids.- Assisted in packing and unpacking of RP-HPLC columns.- Coordinated equipment qualification, calibration, and preventive maintenance (PM) through SAP notifications.- Planned shift activities to ensure timely batch execution.- Reported deviations and… Show more In-Process Optimization & Control:- Monitored process control parameters for downstream operations such as RP-HPLC, crystallizer, centrifuge and lyophilizer.- Executed CIP and SIP for process tanks and 􀏐filtration skids.- Assisted in packing and unpacking of RP-HPLC columns.- Coordinated equipment qualification, calibration, and preventive maintenance (PM) through SAP notifications.- Planned shift activities to ensure timely batch execution.- Reported deviations and investigated root causes to implement corrective actions and improve process efficiency.- Participated in Human Insulin, Insulin Glargine, and Insulin Aspart manufacturing campaigns.- Proficient with 21 CFR Part 210/211.Documentation & Compliance:- Developed and revised SOPs to support process improvements, CAPA implementation, and document updates.- Trained personnel on new or updated SOPs, CAPA actions, and process changes to ensure continuous improvement.- Reviewed BMR for accuracy, including in-process checks and QMS compliance, prior to QA disposition.- Ensured all batch-related activities were documented accurately in BMRs, adhering to GDP, cGMP, and ALCOA guidelines.- Monitored the effectiveness of implemented CAPAs to ensure regulatory compliance and alignment with internal standards. Show less

Penang, Malaysia

- Prepared Complaint Investigation Reports (CIR) based on the inspection conducted inside the Biosafety Cabinet (Level III) for the returned products from customers.- Prepared an operational manual for a smartscope. (Model: Vision Engineering Swift Pro Mon-Dynascope)- Worked together with the Quality Control team to close Non-Conformance Investigation Reports (NCIR) and Device History Record (DHR).- Worked closely together with Quality Control to ensure the… Show more - Prepared Complaint Investigation Reports (CIR) based on the inspection conducted inside the Biosafety Cabinet (Level III) for the returned products from customers.- Prepared an operational manual for a smartscope. (Model: Vision Engineering Swift Pro Mon-Dynascope)- Worked together with the Quality Control team to close Non-Conformance Investigation Reports (NCIR) and Device History Record (DHR).- Worked closely together with Quality Control to ensure the manufactured medical products comply with ISO 13485. Show less

Master Of Engineering - Meng, Bioprocess, Cgpa: 3.95/4.00

Activities and Societies: Member of Post Graduate Student Society of UTM under Faculty of Chemical and Energy Engineering (PGSS FCEE).

Bachelor Of Technology - Btech, Bioprocess

Activities and Societies: - Student Representative, Board of Bioprocess Technology Students (2016-2020) - Production Executive, Exhibition.

Biocon-Kgi Certificate Program In Biosciences

This 4 months course equipped us with a broad-based international curriculum encompassing R&D, Production as per cGMP, Quality Assurance.

Data Analytics

- mastered VLOOKUP, XLOOKUP and Pivot Table functions on Microsoft Excel. - learned query writing techniques using PostgresSQL. - build.

Module 1, Pure Science

Activities and Societies: - 4th Kangaroo Math Competition Malaysia - Honourable Mention - KMNS Academic Ambassadors Programme 2016 - KMNS.

Sijil Pelajaran Malaysia (Spm) -9A'S, Penilaian Menengah Rendah (Pmr) - 8A'S

Activities and Societies: - School Prefect - Malaysian National Chemistry Quiz (K3M) - Merit - Chemistry Science Fair( District Level ).