Diala Alazar
Summary
Quality Assurance Associate with 13 plus years of experience in the diagnosis laboratory and pharmaceutical sectors. Individual known for taking initiatives and who’s responsible for the quality of her work production in a fast-paced environment and under strict deadlines. Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures, and processes as well as analyze any given situation and make hard decisions when it matters.
Overview
22
22
years of professional experience
Work History
Quality Assurance Associate
Biodextris
01.2024 - Current
- Company Overview: A trusted partner of decades of experience that develops, manufactures, and tests a wide range of biologic products. Whether a vaccine, biologic or other product.
- Serves as quality representative to perform the quality review and/or provide quality approval of DCCs, Deviation reports, Laboratory investigations, CAPAs, Change Controls, memorandum, and any other quality related document.
- Oversees and, as necessary verify, processes that impact generation of data (e.g. calibration and maintenance of lab equipment).
- Reviews and approves of incoming laboratory samples and manufacturing starting materials.
- Reviews and approves of Environmental Monitoring (EM) data.
- Reviews and approves of water sampling data.
- Redacts and/or reviews and approves Standard Operating Procedures (SOPs)
- Maintains quality related files and databases up to date.
- Reviews and approves executed Batch Production Records
- Reviews and approves validation protocols.
- Reviews and approves Laboratory Data Record files.
- Reviews and approves stability plans.
- Reviews and approves materials and product specifications.
- Reviews and approves certificate of analysis.
- Participates in self-inspecting activities.
- Participates in external audit activities.
- Performs vendor assessment and qualification.
- Integrates risk assessment principles into the company processes and workflows.
- Integrates LEAN management principles into the company processes and workflows.
- Generates Key Performance Indicators.
- Writing meeting minutes as needed.
- Participates in any activity related to continuous improvement of the company processes.
- Performs other quality related tasks, as needed.
Quality Control Associate
Tetra Bio-Pharma
10.2021 - 08.2023
- Company Overview: Global Leader in Cannabinoid-derived drug discovery and development in Inflammation, Pain, Ophthalmology and Oncology, aimed at bringing novel drugs and treatments to patients and their healthcare providers.
- Review, verify and approve analytical document such as method validation/verification/transfer protocols, reports and analytical test method from contract laboratories and contract manufacturers, to assure completeness and correctness.
- Verify certificates of analysis from contract laboratories, and to record results of analysis accordingly.
- Report, record and investigate of any OOS and OOT results or deviations and propose appropriate CAPAs.
- Establish new specifications for finished products, bulk products and starting materials, to maintain compliance with requirements, methodologies, and references.
- Responsible of stability program: create stability protocol per required guidelines, write stability reports, track stability testing schedule, record stability results, and evaluate the effectiveness of existing programs.
- Inspect and evaluate methods and processes for QC testing contract laboratories.
- Involved in training and transfer of methods to and from QC and contract manufacturers.
- Train teams to reduce quality problems and increase understanding of quality goals.
- Participate in audits and collaborate in writing audit reports regarding contract laboratories.
- Keep supervisor informed regarding risks related to products, process and system.
- Write new standards and procedures.
- Support Change Management system.
- Assist in QC tasks to comply with cGMP practices and regulations.
- Work in cooperation with the different departments, and the contract laboratories to ensure all testing comply with the specifications.
Associate Scientist I (Virology)
Nexelis
06.2021 - 10.2021
- Company Overview: Leading provider of assay development and advanced laboratory testing services in the infectious, metabolic, and oncologic fields.
- Followed effective SOP and CSP in daily clinical testing.
- Adhered to Safety regulations when dealing with Biological and chemical reagents.
- Maintained Good Clinical Laboratory Practices all the time.
- Ensured training is up to date for all job functions.
- Maintained Good Documentation Practices through completing all required documentation.
- Recognized and reported all deviations related to procedures or any aberrant results of testing.
- Tested human serum samples from clinical trials related to development of COVID 19 vaccines by Pseudo typed- Virus Neutralization Assay (PNA).
- Participated in test method qualification and validation for testing Influenza Viruses (including H5N1 H1N1, H3N2, B/Picket, and B/ Washington strains) vaccines responses by HAI (Haemagglutination Inhibition method).
QC Microbiologist I (QC Microbiology)
Green Cross
09.2018 - 01.2021
- Company Overview: Specialized company in the development and commercialization of plasma derivatives, preventative vaccines, recombinant proteins, and therapeutic antibodies. Green Cross is helping patients with infectious or immune diseases lead healthier lives.
- Responsible for performing microbiological tests in microbiology daily lab operations.
- Maintained operational and GMP readiness of the QC areas.
- Participated in complex projects including QC studies to develop mastery of a diverse number of microbiological techniques.
- Performed all lab functions in compliance with cGMP.
- Performed material, product, utilities testing for GMP use in manufacturing.
- Performed Environmental Monitoring of controlled environments per ISO 14644 and USP monitoring:
- O Viable air sampling
- O Non-viable air sampling
- O Viable surface sampling
- Performed monitoring of purified water outlets, water for injection, compressed air points of use, pure steam, and compressed air points of use.
- Performed microbiological testing for the purpose of material/product release, validation and stability.
- Performed QC instrument verification and qualification as needed.
- Provided support for Validation team in the execution of Qualification/ Validation protocols.
- Provided lab support including reagent preparation, growth promotion testing, cleaning, and routine equipment maintenance.
- Recognized and reported aberrant test results and sample conditions. Reported any out-of-specification (OOS), out-of-trend (OOT) or atypical results immediately to the QC Manager and participate in laboratory investigations, as required.
- Ensured training is current for all job functions performed.
- Ordered, stocked, and received laboratory supplies.
- Completed all required documentation legibly and accurately. Maintained good documentation practices when completing logbooks, microbiological work sheets, training records and all other GMP documents. Ensured the integrity and traceability of data generated.
- Supported the implementation of Laboratory Information Management System (LIMS) with the data entry and configuration of the future LIMS applications.
- Drafted new SOPs and updated established SOPs through Change Request process in LIMS.
- Drafted User Requirement Specifications (URS) for new equipment.
- Collaborated with QC Manager to optimize laboratory efficiency, supported lab coordination and provided input to microbiological method validation studies.
Veterinarian - Microbiology Department
Central Laboratories of Animal Health – Jordan Ministry of Agriculture
01.2007 - 01.2010
- Performed Microbiological testing and culturing, Gram Staining, and antibiotic sensitivity tests.
- Established a Standard Operating Procedure (SOP) system for all procedures of tests and calibration of devices and equipment.
- Increased number of working staff.
- Participated as Lecturer in seminars and workshops held by the Ministry, as well as training veterinarian students of JUST.
Veterinarian - Virology department
Central Laboratories of Animal health – Jordan Ministry of Agriculture
01.2003 - 01.2007
- Participated with other colleagues in establishing and initiating the PCR unit, which is now the standard reference for all labs in the country.
- Expanded the margin of serological tests for detection of viral diseases.
- Incremented more types of ELISA tests that widened the range of screened viral diseases.
- Trained a few local and Arab veterinarians on the laboratory diagnostic techniques for the diagnosis of several viral diseases including Avian Influenza held by the Arab Organization for Agricultural Development.
- Trained veterinary undergraduate students of Jordan University of Science and Technology (JUST) as part of their practice program.
Education
Graduate Diploma - QA and RA for Drugs, Food and Cosmetics
AAPS
Toronto01.2023
Bachelor’s degree - Cell and Molecular Biology (BSc)
Concordia University
Montréal01.2016
BSc - Veterinary Medicine
Jordan University of Science and Technology (JUST)
01.2002
Skills
- Software: MS Office Suite
- Knowledge of USP, Ph Eur Pharmacopeia (EP)
- Knowledge of GCP, cGMPs, good documentation practices (GDP) and data integrity requirements
- Knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
- Knowledge of Regulatory Affairs for Pharmaceutical, medical devices, and Natural health products
Languages
English, Arabic, and intermediate French
Training
Training on Data integrity – CAPA – Investigations – Change Request – GMPs – Test Method Validation – GCLP
Professional characteristics
- Ability to multitask under strict deadlines.
- At ease to work independently and as part of a team
- Organisational skills
- Detail oriented and performance oriented
- Interpersonal and communication skills
- Rigour
- Hard working individual
- Manage priorities.
- Adhere to defined timelines
- Negotiation and influential skills
- Interpersonal skills
Timeline
Quality Assurance Associate
Biodextris
01.2024 - Current
Quality Control Associate
Tetra Bio-Pharma
10.2021 - 08.2023
Associate Scientist I (Virology)
Nexelis
06.2021 - 10.2021
QC Microbiologist I (QC Microbiology)
Green Cross
09.2018 - 01.2021
Veterinarian - Microbiology Department
Central Laboratories of Animal Health – Jordan Ministry of Agriculture
01.2007 - 01.2010
Veterinarian - Virology department
Central Laboratories of Animal health – Jordan Ministry of Agriculture
01.2003 - 01.2007
Graduate Diploma - QA and RA for Drugs, Food and Cosmetics
AAPS
Bachelor’s degree - Cell and Molecular Biology (BSc)
Concordia University
BSc - Veterinary Medicine
Jordan University of Science and Technology (JUST)
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