Hajra Shaikh

Regulatory and Quality Assurance associate at Norrizon Sales and Marketing Group - Norrizon groupe de ventes et marketing
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Contact Information
us****@****om
(386) 825-5501
Location
Whitby, Ontario, Canada, CA

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Credentials

  • Certified Clinical Research Professional
    SOCRA
    Jan, 2018
    - Oct, 2024
  • Advanced Pharmacovigilance Workshop
    Abbott
    Jan, 2013
    - Oct, 2024
  • Intellectual Property rights: Biotechnology Patenting & Biodiversity Protecting
    Gujarat University
    Jan, 2013
    - Oct, 2024

Experience

  • Norrizon Sales and Marketing Group - Norrizon groupe de ventes et marketing
    • Canada
    • Manufacturing
    • 1 - 100 Employee
    • Regulatory and Quality Assurance associate
      • Mar 2020 - Present

       Ensure compliance with Health Canada regulations and internal policies related to warehousing, distribution, and importing of products (i.e., NHP, DIN, Medical Device, Cosmetics) ‐‐ read, understand, create, maintain and update Standard Operating Procedures (SOPs) as required Managing the Quality Management System ‐ creating, updating, and maintaining product specifications as required per GMP, ISO13485:2016 and MDSAP Manage shipments of regulated products and conduct quality Inbound and releases Maintaining, updating, and renewing NHP Site License and Medical Device License; ISO and DEL license Manage all types of regulatory submissions Ensure regulated products are compliant (i.e. product testing/artwork review) Communicate with third party regulatory authorities Assist with new product development based on quality and regulatory requirements Approve vendors/manufacturers based on regulatory requirements Approve products based on regulatory requirements Managing the Sustaining Compliance and International Regulatory Affairs team ensuring all regulatory activities including submissions, AE reports, and labelling compliance are delivered within target dates. Formulating and implementing plans for obtaining regulatory approvals and process improvements. Managing critical actions such as recalls and field actions. Assisting with internal audit findings, providing corrective actions and improving processes to ensure compliance. Assisting with resource planning for team members based on projects and tasks; and effectively delegating and prioritizing projects with conflicting or tight timelines. Assisting with product transition from EU MDD to MDR compliance Expertise in Health Canada and FDA regulations. Heavily involved in business development and accounts management to ensure on time launch of products into retailer's POG.

  • Shaklee Corporation
    • United States
    • Wellness and Fitness Services
    • 700 & Above Employee
    • Quality Assurance and Regulatory Affairs Associate
      • 2018 - 2020

       Create and update New Product Assessments for Canadian Regulatory compliance in a timely manner. Expertise in development of Master Production documents, Certificate of Manufacture (CoM), Certificate of Analysis (CoA) and batch record. Supported in artwork generation process; review and approve all product labels. Accounted for processing product complaints/returns and maintaining all documentation to ensure compliance with Health Canada Regulations Audit compliance team member for Regulatory and Internal Audits. Developed Annual Product Quality Reports for accuracy compliance. Maintain and improve knowledge of WHMIS, TDG, CEPA and NFPA criteria for meeting the Canadian Health, Safety and Environment requirements for importation, handling, transporting, and sale and use of Shaklee products. Reviewed method, process and cleaning validations and provided technical guidance to perform validations to meet with the Health Canada and ICH Guidance. Write Standard Operating Procedures as needed Assist in logging of customer change controls. Ensure full compliance with the company’s Health & Safety policies and procedures. Report all hazards to ensure a safe and healthy workplace environment is maintained.

    • Quality Assurance Associate
      • 2016 - 2017

       Review of master manufacturing, packaging, labelling, validations, deviations, raw materials, stability reports and finished product data to assess whether product met regulatory requirements prior to release in Canada. Reviewed finished product, raw material and stability specifications against compendial monographs. Prioritize and lead the team for all the required Batch releases to be accomplished as per timeline. Preparation and review of SOP in accordance with Health Canada requirements and internal policies. Initiated, investigated, and determined corrective and preventative actions for deviations and non‐ conformance. Initiated, executed, and monitored of OOS, Change controls, deviations and CAPA from various client

  • Kidney Disease &Transplant Foundation, India
    • Clinical Research Coordinator II
      • 2015 - 2015

       Worked on enrollment and retention initiatives with Recruitment Team Lead. Obtain and maintain computerized database of all Clinical Trial participants Responsible for accurately complete recruitment tracking log and all applicable clinical trial management systems Expertise in Complete database query for study candidacy and conduct outbound calls for study interest Provide study metrics on a regular basis and provide ongoing feedback regarding outcome of recruitment initiatives. Worked on Informed Consent and screening visits per study protocol and Research SOP. Perform delegated tasks completely and accurately, including review of demographic information, medication history, medical history, obtaining vital signs (blood pressure, heart rate, temperature, and weight, and height measurements) Completed the source documents, case report forms, and data queries in a timely manner, accurately, and completely. Served as primary contact for multiple studies/sites. Worked with QC and QA during audits and audit follow-ups. Assisted the Patient Engagement Lead, Investigators with any other tasks as required. Performed administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Conducted training to new team member. Attended IRB meeting on monthly basis as a trial tram member. Strong Technical Skills.

  • HEMATO-ONCOLOGY CLINIC (AHMEDABAD) PRIVATE LIMITED
    • India
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Clinical Research Coordinator I
      • 2014 - 2015

       Assisted in development and execution of Quality Control processes Prepared for and support QA audits and sponsor monitoring visits Responsible for Study drug management (for outpatient dosings) Assisted in Lab sample processing, labelling, storage, shipment, documentation and record keeping Expertise in Site Regulator Documentation collection and management Designed patient tracking charts using spreadsheets and formulated source documents and data collection charts Worked with study managers and other members of the study teams to ensure study performance meets Participated in review and development of study SOPs and internal procedures Maintain adequate, accurate, complete and legible records Assisted with IRB submission Ensure completion of eligibility requirements prior to enrollment and randomization Schedule patient appointments as per protocol Participate in educational programs, workshops, and seminars to broaden knowledge, update and develop new skills

  • Hi - Tech Cosmetic
    • Chemical Technician
      • 2009 - 2011

      - Kept lab area and all require equipment clean - Maintained equipment and scale calibrated and in working order- Performed general laboratories duties and assisted manager for day to day work- Worked closely with chemist to prepare mid to large scale of product batch- Updated logs and recorded consistently to facilitate comprehensive information for review- Analyzed and compared new arrived raw material with standard sample- Performed quality controlled inspection such as bottle inspection, label inspection, packaging inspection

Education

  • Academy of Applied Pharmaceutical Sciences
    Post Graduation Diploma in Clinical Research, Pharmacovigilance, Quality and Regulatory affairs, Pharmaceutical Sciences
    2019 - 2020
  • School of Sciences, Gujarat University, India
    Master's degree, Clinical Research
    2012 - 2014
  • Seth R.A College Of Science
    Bachelor's degree, Chemistry
    2009 - 2012
  • st.xaviers mirzapur
    High School Diploma, High School/Secondary Diploma Programs
    2007 - 2009

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