Ghazaleh Saeedimotahar, Quality assurance Regulatory affairs

604-***-****, adu2v9@r.postjobfree.com

https://www.linkedin.com/in/ghazaleh-saeedimotahar-09194b206 PERSONAL INFORMATION:

Professional in quality assurance and regulatory affairs, with 8-year management experience in pharmacy and pharmaceutical’s quality control department. EDUCATION:

Post graduated degree in Quality Assurance & Regulatory Affairs professional from AAPS College in Canada.

Doctor of Pharmacy from Medical Science of Private University of Tehran. RESEARCHES:

● Research about unknown toxicity of methanol and its absorption routs

● Inquiry for effects of Statins on NO receptors through blood sampling from the ventricle of rats.

● Investigation about Diclofenac derivatives

● Paw edema technique for anti-inflammatory effects of derivatives of Niflumic acid.

● Creating of Sepsis in rats for assisting of antibacterial effects.

● Assisting of anti seizures effects by creating tonic-clonic model. EXPERIENCES:

Canadian Experiences:

Quality Assurance Coordinator at Viva Pharmaceutical December 2022-Current

Associate in Walmart retail store. September 2021-current

Customer contact in Palacio construction from (Volunteer). June 2021-August 2021

Contraction management. June 2021-September 2021 Pharmacy:

Asal pharmacy 2012 November- May 2021

Regulatory affairs (Qualified person) January 2019-May 2021

Regulatory affairs of Quality of Life (QOF, Canadian company) in Iran: o Submitted document to apply importation license of Natural bulk products.(Semi- Finished product).

o Prepare and/or review responses to Ministry of Health in a timely manner. Ghazaleh Saeedimotahar, Quality assurance Regulatory affairs 604-***-****, adu2v9@r.postjobfree.com

https://www.linkedin.com/in/ghazaleh-saeedimotahar-09194b206 o Review product labels, completing, reviewing and assessment of Change Controls, regarding of the authorization requirement.

Quality control management: June 2017 to May 2021

● Middle management of Darlan Daru Pharmaceutical Company. o Preparing URS for laboratory equipment.

o Preparing VMP and QTA.

o Involving in laboratory layouts and designing (zonings, material and personnel flow, etc). o Preparing critical documents (COAs, BR, SoPs,…) and documentation (Regarding GDP).

o Laboratory personnel training.

o Method validation, Equipment qualification.

o Labeling and Inspection of the products in warehouse (Color coding,), and batch approval.

o Water treatment system validation and control.

o In-process controls.

o Line approval and line clearance approval.

Quality control assistant: December 2016- June 2017

Preparing of Media fill instruction and SoP for IPPC company.

Risk assessments and Risk management

o Batch records preparation

R&D Expert: October 2016- December 2016

o Running of artificial tears production line in IPPC Pharmaceutical Company. o CTD preparation for sterile products in LVPs and SVPs. o Method validation development.

Quality control Expert: February 2013- February 2015

● Expert in the raw material and water lab in Institute Pasteur.

Method verification and Method Validation.

Preparing of Standard Operation Procedure (SOP)

Quality control analyst II (Approval of raw material examinations)

In-Process controls

Ghazaleh Saeedimotahar, Quality assurance Regulatory affairs 604-***-****, adu2v9@r.postjobfree.com

https://www.linkedin.com/in/ghazaleh-saeedimotahar-09194b206 CERTIFICATES & COURSES:

o management spillage of chemical materials

o ISO 9001

o Economic management and financial management

o Safety and risk in the laboratory

o The principle of GMP in Biological and sterile products o Microbial control in the clean rooms

o Documentary and layout necessities

o Technology transfer rules

o Flow cytometry course for 4hrs. (Sweden license) o Data analysis course for 4hrs. (Sweden license)

o HPLC for 4 hrs. (Sweden license)

o Pharmacovigilance

o Pharmaceutical Marketing

o Biological & Vaccination research institute

o Bioinformatic

o PQR

REFERENCES: It will be prepared based on your request.

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