Gloria Torregrosa Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto Y Alrededores, Canadá

• Perform validation (IQ, OQ, PQ) of various systems and processes • Initiate and resolve deviation investigations (OOS and OOT), CAPA, and troubleshooting during Validation and GMP manufacturing• Execute GMP manufacturing of Class II medical devices and drug products. • Contribute to the research and development of novel medical devices and drugs. Product Development• Assist in documentation to support 510(k) and regulatory applications• Assist in the development, authoring, and validation of GLP Test Methods to support Validation and GMP manufacturing• Coordination with team members to ensure all aspects of activity within the product process development and validation group adhere to required policies and procedures, including safety and training • Design and execution of shelf-life studies including physical, chemical, and biological evaluation of final products• Maintenance of Controlled Environment and associated quality controls and practices• Involvement in the research and development of new medical device and drug product lines• Sourcing and inventory management of raw materials for production• Organize workload and meet deadlines in a fast-paced, changing environment• Interact with suppliers and contract testing facilities as required

Toronto Y Alrededores, Canadá

Maintaining good documentation systems and report formats for all laboratory procedures, processes, and equipmentWriting and Developing Standard Operational Procedures (SOPs)Ensuring all analyses performed meet GMP, regulatory, and compendial requirementsAntimicrobial Effectiveness testing USP <51>Growth Promotion testing USP <51> <61> <62> <71>Antibiotics Microbial Assay-Turbidimetric Method USP <81>Biological Indicators-Resistance Performance Tests USP <55>Crystallinity USP <695>Water Testing USP <1231>Sterility Testing USP <71>Method Suitability Testing of Sterile and Non-Sterile Products USP <71>Microbiological Examination of Non-Sterile Products, Test for Specified Microorganisms USP <61> <62> Ph. Eur <2.6.12> <2.6.13>Biodurden Assessment ANSI/AAMI/ISO

Toronto Y Alrededores, Canadá

Collect, process, and test samples of chemical components, bulk products, finished products, and in process material followed by Standard Operating Procedures (SOPs)Prepare microbiological growth media and solutions, and ensure media performance through growth promotion testPerform microbial limit and pathogen tests for a variety of cosmetics productsPerform Gram Stain and microscopic examination of physiological, morphological, and cultural characteristics of bacteria and other microorganismsConduct periodic environmental monitoring in the manufacturing area and production linesDocument all results of product testing and maintain daily records

Toronto Y Alrededores, Canadá

Provide filling & packaging specification and standard to the line leaders in a timely mannerAudit lines to ensure: Line clearance and start-up forms are completed All filling and packaging requirements are met for the product by doing the hourly checks for -fill weight, torque measurement, aesthetics, and other quality parametersAddress sub-standard and other quality issues with the QA supervisor/QA manager and put the product on “hold” when necessaryFill and complete QA line inspection forms in a timely manner with all relevant detailsEnsure that cGMP is maintained on all production assembly lines at all timesWork with all relevant departments to implement the corrective action that will resolve the root cause of the problem on the lineUpdate QA Supervisor / QA Manager when actual fill weight is higher or lower than the BOMEnsure that all finished goods are audited and released in a timely mannerTrained others and made sure that they were able to follow the procedures accordingly

Baza, Granada

Internships in FIBAO. Hospital Laboratory. Baza, Granada, Spain. Microbiology department: - Analyzed samples from patients - Plated, isolated, and identified microorganism in different samples - Sterilization, aseptic techniques, inoculation, and incubation - Experience in different plating methods for selective cultures - Performed of ANA (antinuclear antibodies), IFI (Indirect immunofluorescence), and DIF (Direct immunofluorescence)Biochemistry Department: - Analyzed the different aspects of blood serum (texture and viscosity) - Analyzed hormonal parameters - Performed internal and external quality checksHematology department: - Identified the different blood groups - Conduct chemical analyses of body fluids, such as blood, and used microscope or automatic analyzer to find abnormalities - Examine cells stained with dye to locate abnormalities - In blood studied and participate in the clinical cases with the hematologist expert, such as leukemia and lymphomaAssisted reproduction area: - Determined fertility levels of individuals - Preservation of gametes and embryos for future use - Prepare sperm for in vitro fertilization (IVF) - Embryo selection for transfer to recipient women

Master Of Science, Degree In Biology (Evaluated By Wes), Biology/Biological Sciences, General

- Identified and analyzed material of biological origin and its anomalies - Isolation, enumeration, and identification of microorganisms.

Biotechnology-Postgraduate Diploma, Science, Gpa 3.867

- Isolation and purification of DNA, RNA, and proteins - Restriction Digestion of Lambda DNA - Agarose Gel Electrophoresis - Lysis.

Estudiante, English

Able to handle the main structures of the English language with confidence, demonstrate good knowledge of a range of specific.