Mahya D.
Quality Assurance Coordinator at PERFECT Sports- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Experience
-
PERFECT Sports
-
Canada
-
Wellness and Fitness Services
-
1 - 100 Employee
-
Quality Assurance Coordinator
-
2020 - Present
• Produce Batch Records for each order received. • Maintain other documents and files related to the production of Batch Records (Master Formula, Master Manufacturing Record, Finished Product Testing Specifications), and ensure that any changes are properly documented (change controls). • Perform Data analysis, statistics, and report preparation, while maintaining and utilizing Quality Assurance databases. • Write new SOPs, method development reports, method qualification reports, and protocols for newly developed bio-analytical assays. • Operate on a daily basis various Quality Systems such as SAP, and LIMS. • Possess a sound understanding of industry guidelines (GMP, GDP, and GLP) Show less
-
-
-
Pasteur Institute of Iran
-
Pharmaceutical Manufacturing
-
100 - 200 Employee
-
Clinical Project Manager
-
Mar 2014 - Jul 2020
HIV polytope candidate vaccine formulation with N-trimethyl chitosan nanoparticles as a potent delivery system(thesis) Publication of original scientific work in high-quality journals Additional experience in standard molecular and cell biology techniques a strong plus (mammalian cell culture, transfection, SDS-PAGE, ELISA/MSD, qPCR) Reading and understanding project protocol documents Quality review the entry and maintenance of data in the applicable study tracking database Performed Data analysis, statistics, and report preparation, maintain and utilize Quality Assurance databases Wrote new SOP's, method development reports, method qualification reports and protocols for newly developed bio-analytical assays. Operated on daily basis various Quality Systems such as Phoenix, SAP, LIMS; Ensures the confidentiality of study protocols and subjects is maintained Ensures security of all study data and study/regulatory documents Acting as backup to the Assistant Clinical Project Manager as needed Developed new bio-analytical test methods, performed assay qualification and inter-department method transfer. Performed good documentation practices when generating raw data, reports, and SOPs. Show less
-
-
-
Darou Pakhsh (شرکت کارخانجات داروپخش)
-
Iran
-
Pharmaceutical Manufacturing
-
100 - 200 Employee
-
Quality Control Supervisor/Manager
-
2010 - 2014
Owned the lifecycle of assigned product offerings including scope, design, implementation, & support; Developed and presented comprehensive, accurate, detailed technical reports supporting testing or analytical analysis; Performed testing on various forms of raw materials; Responsible for the content loading and maintenance of information into the company’s portal; Prepared Quality Manuals, Standard Operating Procedures and Quality plans; Acted as focal point for all internal and external audits; Worked with Viscosity test (Brookfield ), pH Meter , Gas Chromatography (GC) High performance liquid chromatography (HPLC) , Ultraviolet (UV); Acted as a liaison between engineering, sourcing, and operations and various field functions. Communicate and resolve issues with Manager Show less
-
-