Azra Shakila Ahasan
Scarborough,Canada
Summary
Experienced pharmaceutical professional with over 7 years in highly professional environments. Responsible and energetic executive skilled in multitasking. Strong documentation skills and ability to manage internal and external stakeholders. Proficient in handling multiple tasks simultaneously, ensuring seamless coordination and effective communication with all parties involved. Dedication to excellence and commitment to delivering results make a valuable asset in any pharmaceutical setting.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Processing Technologist
Thermo Fisher Scientific (Patheon)
11.2023 - Current
- Process and manufacture products in accordance with written processing orders
- Prepare manufacturing areas and equipment for the production of pharmaceutical products
- Streamlined workflow processes with the implementation of Lean Manufacturing techniques in daily tasks.
- Clean processing equipment and rooms in accordance with written Standard Operating Procedures (SOPs) and established Good Manufacturing Practices (GMP)
- Ensure product quality meets the standards of company, clients and applicable regulatory agencies including Health Products and Food Branch Inspectorate (HPFBI), United States of Food and Drug Administration (USFDA) and European Medicines Agency (EMEA)
- Perform In-Process Checks (IPC), complete reconciliation and other documentation and sampling of bulk products
- Follow the required Environmental Health and Safety (EH&S) and Good Manufacturing Practices (GMP)
- Routinely monitor and record environmental conditions in the processing area and any other duties assigned by the Supervisor
- Reduced downtime and increase productivity troubleshooting issues promptly.
- Identify and escalate product and process related issues in timely manner.
- Maintain a safe working environment and report potential hazards.
Pharmacy Assistant
Shoppers Drug Mart
01.2022 - 11.2023
- Greet patients and confirm the accuracy of all pertinent prescription information prior to filling
- Enter all relevant data regarding patient care information into HealthWatch software along with third party adjudication where required and necessary
- Select medications for dispensing, according to standard operating procedure
- Efficiently count or measure, package, label prescriptions, ensure all relevant information
- Maintenance of pharmacy stock through inventory control and purchase order day to day basis
- Handling general OTC enquiries from patients and referral to Pharmacist where required
- Responding to the telephone calls, faxes and record all information
- Provide support and assistance to the pharmacists as required, ultimately with a view to enhancing the pharmacist/patient relationship.
Customer Fulfillment Associate, OMNI (Ecommerce)
Walmart Canada Inc.
10.2020 - 10.2021
- Picked, labelled and packed product based on daily orders and meeting specifics of customer orders in a timely manner
- Kept products separated, organized and loaded in delivery trucks
- Monitored product quality frequently, reporting problems to mitigate safety issues
- Dispensed the right order to the specific customer at pickup area
- Utilized continuous improvement mindset and assisted in identifying opportunities to improve processes
- Reported any mechanical problems and performing other duties as assigned.
Senior Executive, International Regulatory Affairs
Beximco Pharmaceuticals Limited
08.2014 - 05.2020
- Provided guidance and support to businesses on regulatory policies and procedures and ensured internal compliance with regulatory requirements
- Compiled e-CTD dossier (ANDA, ANDS) for regulatory submission within defined time schedules and in accordance with country specific requirements of Australia, USA and Canada
- Prepared and evaluated artworks (labeling, packaging and advertising material) in collaboration with design department as per CMC guidance of Australia, USA and Canada
- Renewed Drug establishment license (DEL) and site license periodically
- Maintained continuous upkeep with contemporary regulatory guidance and labeling guidance of USA and Canada
- Reviewed Executed batch manufacturing report (EBMR), Batch packaging record (BPR), Certificate of analysis (CoA) accordance with Standard testing procedure (STP) and Specification, Process validation reports, Accelerated and Long-term stability report, TSE-BSE certificate, API supplier documents accordance with Drug master file (DMF), Site master file (SMF) and Packaging Material supplier documents received from stakeholders for adequacy and accuracy (as applicable) as per respective regional regulatory requirements
- Reviewed draft dossiers received from consultant prior submission
- Responded the queries from consultant and regulatory agency
- Archived submitted dossier and post approval documentation properly
- Submitted annual report, responded to product complaints and further queries for approved and post marketed products in US market
- Conducted assessments and proposed improvements to methods, systems and procedures in areas such as operations, research and development, quality management, record management and communications as per regulatory requirements
- Prepared and revised SOPs and Guidelines for regulated market products and site.
- Prepared NOC for importing innovator products from overseas market and maintained records of purchased innovator products
- Processed all invoices from regulatory agency and partners and ensured payment in due time
- Performed periodic internal audits and handled quality audits of external stakeholders, consultants/partners and regulatory agencies (USFDA, Health Canada, TGA, MHRA)
- Collaborated with pharmacovigilance team as regulatory designee for Corporate Pharmacovigilance
Education
Post Graduate Diploma - Pharmaceutical Regulatory Affairs
Toronto Institute of Pharmaceutical Technology
Toronto, ON10.2023
Master of Science - Pharmacy
State University of Bangladesh
Dhaka, Bangladesh04.2016
Bachelor of Science - Phamacy
East West University, Bangladesh
06.2014
Skills
- Regulatory Compliance
- Regulatory Submission
- GMP and GDP
- Technical writing and Documentation
- Quality review
- Attention to detail
- Team Management
- Communication
- Microsoft Office (Word, Excel)
- Lorenz Docubridge for US and Canada
- Adobe acrobat Professional (7 through
- Lorenz eValidator
Languages
English
Full Professional
Bengali
Native or Bilingual
Hindi
Professional Working
Urdu
Professional Working
Certification
- [USFDA filings approvals and post approval changes under GMP compliant system and how to avoid FDA's 483] [Pristene Knowledge Group] [Nov,2016]
Timeline
Processing Technologist
Thermo Fisher Scientific (Patheon)
11.2023 - Current
Pharmacy Assistant
Shoppers Drug Mart
01.2022 - 11.2023
Customer Fulfillment Associate, OMNI (Ecommerce)
Walmart Canada Inc.
10.2020 - 10.2021
Senior Executive, International Regulatory Affairs
Beximco Pharmaceuticals Limited
08.2014 - 05.2020
Post Graduate Diploma - Pharmaceutical Regulatory Affairs
Toronto Institute of Pharmaceutical Technology
Master of Science - Pharmacy
State University of Bangladesh
Bachelor of Science - Phamacy
East West University, Bangladesh
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