SHYAMALA DEVI ASOHAN
Summary
Experienced Quality professional with a demonstrated history of working in the pharmaceutical industry with 8+ years of experience in QC/QA functions. Possess well-honed analytical and problem solving skills and broad range of hands-on and theoretical experience in analytical testings and instruments.
Detailed oriented person with extensive experience in executing laboratory/deviation/CAPA investigations. Known for thorough and efficient investigations resulted in well-written reports. Adept at providing support and developing new processes through ongoing work and enhancement solutions.
Overview
8
8
years of professional experience
Work History
Quality Assurance Executive
Prestige BioPharma Ltd
12.2022 - Current
- Lead Document Management Processes to maintain global and internal quality standards.
- Expert in documentation systems (electronic and paper-based) to assist cross-functional teams in assessment and implementation of the documentation management and control processes.
- Co-lead and support quality management system including deviation, validation, change control and CAPA to ensure systems are managed in accordance with regulatory requirements and internal quality standards.
- Well versed in using Montrium eQMS platform to document quality management system (QMS) activities.
- Provide Quality Review and oversight of site GxP documentation related to the operation of pre-clinical and characterization laboratory to ensure compliance with regulatory requirements.
- Assist in quality review and submission of regulatory documents and reports.
- Conduct regular internal audits of studies and processes, ensuring compliance with regulations and company policies.
- Led cross-functional teams to identify root causes of issues, driving continuous improvement efforts.
- Act as trainer to train staffs on quality standards, procedures and best practices.
- Participate in regulatory inspections and interact directly with regulatory inspectors.
- Well versed in regulation and guidelines requirements of ICH Guidelines, PIC/S Guideline, OECD Documents of Good Laboratory Practices (GLP) and ISO 17025 and ISO 9001 Standards.
QC Team Lead
Biocon Sdn Bhd
10.2021 - 11.2022
- Manage QC Analysts and QC laboratory operation for In-Process team.
- Plan and supervise QC testing of products completed in stipulated time and able to provide accurate and timely result to maintain TAT of production
- Primary investigator on non-conformance - Lab Incident, Out of Specification (OOS), Out of Trend (OOT), Deviation and etc.
- Well experienced in utilizing investigation tools for investigations – Fishbone Analysis, Why-Why Analysis, It is/Is not Analysis and etc.
- Trackwise system user in handling Quality Management Systems (QMS) – Corrective Action and Preventive Action (CAPA), Change Control, CAPA Effectiveness Monitoring and etc.
- Literate in reviewing internal and cross functional team documents – Analytical Technical Reports, Audit trails, Product Quality Review reports, Master Formula Record (MFR), Batch Manufacturing Record (BMR), hold time study protocols, Process Performance Qualification Protocols and etc.
- Responsible for develop, draft and review of SOPs, EOPs and Specifications in accordance with the GMP standard
QC Chemist (AS&T)
Biocon Sdn Bhd
01.2020 - 10.2021
- Responsible for providing technical expertise and support in troubleshooting laboratory instruments to support routine testing
- Proficient in executing calibration of type A, B and C laboratory instruments and complies with regulatory requirements and SOP.
- Literate in closing and reviewing calibration reports, QMS elements related to calibration activities of laboratory instruments.
- Abide strictly with calibration and preventive maintenance master planner for execution
- Liaise with third party vendor for any discussions related to breakdown or maintenance of laboratory instruments.
- Engaged with the execution of new method transfer, method validation and laboratory instruments and equipment qualification activities (IQ, OQ & PQ)
- Keep updated to latest regulatory requirements such 21 CFR Part 11 and Annex 11 for all computerized system in laboratory.
QC Analyst
Biocon Sdn Bhd
11.2016 - 12.2019
- Directly involved for audit readiness from regulatory bodies such as EMA, USFDA, Health Canada and NPRA.
- Hands-on with GDP, GLP and QMS practices.
- Comply to SOP, EOP and specifications during testing.
- Recorded, reviewed, and approved co-analyst test data and performed audit trail for data generated.
- Maintain and update product data spreadsheet to monitor batch performance
- Well capable in handling in-process testing on API for Biosimilars: Human Insulin, Insulin Glargine, Insulin Aspart and Insulin Detemir
- Excel in performing analytical testing for qualitative and quantitative analysis using HPLC, UPLC, GC-FID, pH Meter, and UV-Vis spectrophotometer.
- Acquainted with testing on cleaning samples from various production department using TOC Analyzer for CIP and SIP verifications.
- Conducted in-process residual solvent test from solvent recovery plant using GC-FID and Karl Fischer Auto Titration.
- Experienced in handling Finished Drug Product samples.
- Conducted test for assay value, density, and pH.
- Documented quality control reports for samples with detailed summary of test conducted for approval or rejection useful for further analysis
Education
Master - Pharmaceutical Legislation And Regulatory Control
University Malaya (UM)
Malaysia10.2026
Certificate in Bioscience - Bioscience
Keck Graduate Institute
10.2016
Bachelor of Science - Resource Biotechnology
University Malaysia Sarawak (UNIMAS)
11.2015
Skills
- Excellent time management and attention to detail
- Strong analytical thinking and problem solving
- Excellent communication and literacy skills, both verbal and written
- Quality culture mentality and good manufacturing compliance knowledge
- Work effectively in fast-paced environment
- Proven ability to learn quickly and adapt to new situations
- Skilled at working independently and collaboratively in a team environment
- Passionate about learning and committed to continual improvement
Additional Information
Expected Salary - SGD4500 (Negotiable)
Last Withdrawn Salary - SGD3900
Notice Period - 2 months
Reason for leaving - I'm seeking new challenges and role that aligned better with my career goals. I wanted to contribute my skills and expertise to a company where I could make a more significant impact.
Languages
English
Bilingual or Proficient (C2)
Tamil
Bilingual or Proficient (C2)
Malay
Bilingual or Proficient (C2)
Timeline
Quality Assurance Executive
Prestige BioPharma Ltd
12.2022 - Current
QC Team Lead
Biocon Sdn Bhd
10.2021 - 11.2022
QC Chemist (AS&T)
Biocon Sdn Bhd
01.2020 - 10.2021
QC Analyst
Biocon Sdn Bhd
11.2016 - 12.2019
Master - Pharmaceutical Legislation And Regulatory Control
University Malaya (UM)
Certificate in Bioscience - Bioscience
Keck Graduate Institute
Bachelor of Science - Resource Biotechnology
University Malaysia Sarawak (UNIMAS)
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