Pradeep Kumar Kovelakaru
Vancouver
Summary
Dynamic professional with 1.5 years of experience in the pharmacovigilance industry, specializing as an associate with a strong command of medical terminology, MedDRA, and WHO Drug Dictionary. Over 3 years of experience as a QA technician in the food manufacturing sector, possessing extensive knowledge of SQF and HACCP standards. Proven ability to enhance production personnel adherence to Good Manufacturing Practices (GMP) and implement effective Hazard Analysis Critical Control Point (HACCP) strategies. Committed to ensuring compliance and quality in all aspects of pharmaceutical and food safety operations.
Overview
8
8
years of professional experience
Work History
Quality Assurance Technician
JORIKI INC
09.2018 - 02.2019
- Performs various laboratory functions such as chemical titrations and microbiological plating and analyses.
- Calibrates, monitors and maintains laboratory equipment.
- Performs various in-line quality control checks.
- Performs various inspections, checks, sampling procedures for the manufacturing process in accordance with SOPs.
- Ensures and verifies the cleaning of equipment and process areas.
- Reviews data and reports any non-conformances.
Quality Assurance Technician
Verka Food Products LTD
SURREY , British Columbia
03.2016 - 08.2018
- Interpret, implement and maintain quality assurance/ quality control standards and procedures.
- Perform QC monitoring on line (Induction seal, weight checks, Coding, Metal Detection, Labels, Pallet Pattern).
- Conducted root cause analyses for identified defects, implementing preventive measures to minimize recurrence rates.
- Performed thorough inspections of incoming materials and outgoing products.
- Helped uncover and fix production problems in order to reduce overall defect rates.
- Reduced customer complaints with proactive identification of potential issues during routine testing procedures.
- Maintained accurate documentation of all quality-related activities, facilitating easy access to records when needed.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Developed strong relationships with suppliers, working collaboratively to ensure materials met required quality standards.
Pharmacy Assistant
Bond Pharmacy
Vancouver, British Columbia
01.2014 - 02.2015
- Help with day-to-day running pharmacy
- Medication dispensing, inventory management, customer service, and administrative duties.
- Processing prescription orders, ensuring accuracy and adherence to legal and regulatory requirements.
- Providing customer service by answering inquiries, addressing customer concerns, and offering information on over-the-counter medications and healthcare products.
Pharmacovigilance Associate
Tata Consultancy Services
MUMBAI
07.2011 - 11.2012
- 1.5 years of expertise in Drug Safety, Pharmacovigilance activities
- Safety databases worked on: ARGUS, MedDRA.
- Case processing knowledge for Serious, Non-Serious and Fatal cases. Worked on all types of ICSR like clinical trials, Spontaneous, Legal, Literature, Line Listing and Post market Surveillance.
- Reviewed, triage, assessed and processed individual case safety reports and submitted as per priority timelines reporting them to regulatory authorities – FDA and European Health authorities.
- Worked on different case types: Spontaneous, Legal, Line Listings and Literature.
- Attention to detail to applicable regulations, SOPs and internal guidelines.
- Attention to detail, working under pressure, target oriented and time management
- Additional skillset with Drug safety and AE reporting: Quality control and was integral part of auditing team
- Co-ordinated with MedDRA team for AE reporting and due diligence of cases been submitted to RA
- Flexible to learn new databases and open to opportunities which will help in my growth
- Strong and excellent computer skills: Microsoft Word, Outlook, Power Point and Excel, and Project Management.
- Mentored Client new trainees in my team and signing them off on ICSR activities – for 3 months
- Completion of data entry, including Medical Narrative writing and manual coding as per MeDRA conventions.
Education
Master’s - Administrative Sciences
Farleigh Dickinson University
Vancouver, BC05.2014
Bachelor of Science - Pharmaceutical Sciences
Vikas College of Pharmacy
ANDHRA PRADESH, INDIA.04-2011
Skills
- Experienced in implementing quality control measures in food manufacturing
- Knowledge of HACCP and SQF standards
- Management of production teams following GMP and HACCP standards
- In-depth knowledge of CFIA regulations
- Proficient in drug safety and pharmacovigilance for 15 years
- Therapeutic area worked on: Specialty Medicine and consumer care, Cardiovascular and Primary Health
- Experience with ARGUS and MedDRA
- Case processing expertise in serious and non-serious incidents
- Reviewed, triage, assessed and processed individual case safety reports and submitted as per priority timelines reporting them to the regulatory authorities – FDA and European Health authorities
- Attention to detail to applicable regulations, SOPs and internal guidelines
- Additional skillset with Drug safety and AE reporting: Quality control and was an integral part of auditing team
Sundry Details
- Got 7th rank in pharmacy quiz competition held at Siddhartha College of pharmacy, Vijayawada.
- Attended and participated in 3rd IPA.
- Attended and Participated in 63nd IPC (Indian Pharmaceutical congress) held at Bangalore Exhibition Centre, Bangalore.
- Attended two days’ workshop on “pharmacy” organized by Siddhartha College of pharmacy, Vijayawada.
- Published my research article in journal.
- Attended several guest lectures, workshops, seminars and symposia organized
- A Participant in the “Fire and Safety” Kings Fire Safety Health and Environmental Engineers India
Education and Training
- MS Excel, MS Office Oracle Argus Safety Database 7.0
- Data Entry
- Case Processing
Personal Strengths
- Good Communication and Presentation skills
- Passion to Learn New Concepts
- Speed of Thought and Implementation
- Self-Motivated
- Team Management
Area of Interest
Clinical Research, Pharmacovigilance, Production, Formulation, Quality Control, Quality Analysis and Research.
Languages
English
Timeline
Quality Assurance Technician
JORIKI INC
09.2018 - 02.2019
Quality Assurance Technician
Verka Food Products LTD
03.2016 - 08.2018
Pharmacy Assistant
Bond Pharmacy
01.2014 - 02.2015
Pharmacovigilance Associate
Tata Consultancy Services
07.2011 - 11.2012
Master’s - Administrative Sciences
Farleigh Dickinson University
Bachelor of Science - Pharmaceutical Sciences
Vikas College of Pharmacy
Similar Profiles
Piotr MorawiecPiotr Morawiec
Maintenance Supervisor at Joriki IncMaintenance Supervisor at Joriki Inc
Rajeevan KugananthanRajeevan Kugananthan
Production Worker at joriki incProduction Worker at joriki inc
Surekanth KirupairasaSurekanth Kirupairasa
Food and Beverage Case Packer Operator at Joriki IncFood and Beverage Case Packer Operator at Joriki Inc
Nola ChaseNola Chase
Front of House Employee at Merci Boulangerie BakeryFront of House Employee at Merci Boulangerie Bakery
ANDRES BLANCOANDRES BLANCO
Civil Engineer at AG CIVILCivil Engineer at AG CIVIL