VIVEK VINAYAKUMAR
Pharmaceutical processing technologist
Scarborough,ON
Summary
Reliable, detail-oriented, conscientious clinical pharmacist with a comprehensive knowledge of practices and operational techniques in pharmaceutical science having strong background in prescription evaluation,clinical trials, medical researches, quality operations and drug testing.
Overview
4
4
years of professional experience
Work History
Pharmaceutical Production Technician
APOTEX INC.
08.2022 - Current
- Works in compliance with all departmental and company Health and Safety policies, SOPs, cGMP procedures and other governmental regulations.
- Uses appropriate personal safety equipment and follows safety procedures.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- Use LIMS Software to enter data into batch ticketing system and checked information for accuracy.
- Follow safety processes and protocols while moving hazardous chemicals and operating heavy machinery to avoid and accidents.
Pharmaceutical Processing Technologist
Thermofisher Scientific
05.2022 - 08.2022
- Utilized critical thinking skills and application of acquired technical knowledge to support projects related to formulations, manufacturing processes and packaging components for SCMP, New Product Development (NPD) and existing product innovations.
- Provided first level technical support to experimental trials in order to evaluate changes in manufacturing and packaging processes.
- Provided input and contributed to the preparation of RLD characterization reports on inhalation Quality Target Product Profiles and identify Critical Quality Attributes.
- Worked in close collaboration with cross functional teams and technical experts to write investigation reports related to stability/submission batches, deviations, excursions and/or packaging studies.
Pharmacy Assistant
Walmart Pharmacy
04.2021 - 04.2022
- Operated cash register and other front counter tasks to facilitate daily operations.
- Counted and labeled prescriptions with correct item and quantity.
- Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medication-specific issues.
- Processed incoming drug orders by checking deliveries against paperwork and updating computer system.
- Prepared unit dose medications and compounded medications in accordance with NAPRA standards.
- Good knowledge in computer system like Kroll, Fillware and Meditech.
QC Chemist
Akesiss Pharma Private Limited
06.2020 - 03.2021
- Good knowledge and experience in using analytical
techniques and instrumentation's. - Expertise in gas chromatography, mass spectrometry,
liquid chromatography, or inductively coupled plasma
Comprehensive knowledge in NMR ,IR , HPLC, UPLC , IC,wet chemistry and other separation techniques
Validated analytical testing procedures, including
dissolution methods, for drug substance and drug product. - Ensured that all compliance program's, such as the
Global Quality policies and procedures, Safety and
Environment policies, and HR policies, are followed. - Initial testing, stability testing, in-process testing, and raw materials testing were all carried out as per the guidelines.
- Assessed the drug substance's stability and determined its physicochemical properties.
- Evaluated the stability of the trial formulations under
forced degradation conditions.
Clinical Pharmacy Intern
Karuna Medical Collage Hospital
07.2019 - 09.2020
- Acted as the point of contact for the clinical group for assigned trials when dealing with internal and external customers.
- Preparation of study related documentation,
review completion of study documents (Case Report Forms and Source Documents). - Performed clinical and study procedures as per study protocol.
- Detailed review of subject and study documentation, case report form (CRFs) and source documents.
- Ensured the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and Standard Operating Procedures (SOPs) at all times.
- Practiced anti-microbial stewardship programme.
- Performed medication error monitoring and CAPA analysis.
Education
Graduate Certificate - Project Management
Durham College
Oshawa, ON04.2022
Advanced PG Diploma - Pharmaceutical Food Science Technology
Durham College
Oshawa, ON08.2021
Doctor of Pharmacy - PharmD
Kerala University Of Health Science
Kerala, India09.2020
Skills
- EPA Regulations
- Good Clinical Practice
- Case Report Management
- Policy Standards and Guidelines
- Trial Methodologies
- Regulatory Compliance and Documentation
Timeline
Pharmaceutical Production Technician
APOTEX INC.
08.2022 - Current
Pharmaceutical Processing Technologist
Thermofisher Scientific
05.2022 - 08.2022
Pharmacy Assistant
Walmart Pharmacy
04.2021 - 04.2022
QC Chemist
Akesiss Pharma Private Limited
06.2020 - 03.2021
Clinical Pharmacy Intern
Karuna Medical Collage Hospital
07.2019 - 09.2020
Graduate Certificate - Project Management
Durham College
Advanced PG Diploma - Pharmaceutical Food Science Technology
Durham College
Doctor of Pharmacy - PharmD
Kerala University Of Health Science
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