Mario Ignacio Ami Email & Phone Number

Madrid, Es

Brussels, Brussels Region, Belgium

Melbourne, Victoria, Australia

Andes Biotech is an Australian / European science-based agency that strives to meet the needs of the client in every way.Our philosophy and culture embrace core values, which govern every interaction with our customers, leading to our reputation for providing services of uncompromising quality and integrity.We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs. Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.Andes Biotech Life Science Consulting experience is varied working with Listed and Registered Medicines, OTC products, Complementary medicines, Medical Devices, Food Products and Cosmetics.Let our team of experts assist your organisation with bringing new products to the market, as well as provide specialised regulatory knowledge that will maintain your current product portfolio’s compliance to industry standards, and place the quality of your product where it needs to be.

Australia

Quality, Compliance and Regulatory Consultant | www.commercialeyes.com.auCore Responsibilities:Responsible for the preparation and submission of a range of compliance documents, regulatory applications and related activities for Australia and New Zealand.• Management and preparation of GMP clearance applications for submission to regulatory agencies, as required. • Quality Management System specialist: Preparation, Maintenace, Optimization for Pharmaceutical, Food, Biotech and Medical devices companies.• Review of batch documentation records and Release for Supply (Batch certification).• Preparation, update and control of internal compliance templates, and electronic document.• Provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices.• Provide support to clients with the maintenance of current registrations and listings.• Review, critically evaluate, prepare and submit regulatory dossiers.• Assist clients in responding to Health Authority questions.• Lead, Plan, Review of CAPAs, Risk Assessment, Deviations, Change Control, Recalls, Vendor qualifications, etc.• Vendor/Supplier CMOs qualifications.• Staff training

Sunshine West, Victoria, Australia

Responsible for the following:• To utilise and manage the Quality Management Systems so as to maintain a state of acceptable control over the Packaging and Storage operations at Golden Health (issuing and handling SOP’s, OOS’s, CAPA’s, Deviations, Reworks, Validations, Mock recalls, etc.)• To oversee the dispositioning (release, quarantine, rejection) of all packaging materials, bulk product and finished products utilised and produced by the business.• To evaluate every packaging batch record and bulk product certificate of analysis for compliance with the specifications.• To approve and monitor contract analysis laboratories providing services to GH.• To liaise with the manufacturers of bulk code share products.• To approve specifications and sampling / inspection instructions for packaging materials and components used by the business.• To conduct routine inspections of the Facility thus ensuring the systems of preventative maintenance, cleaning and pest control are evident and operating acceptably,• To ensure the appropriate validation & qualification work is completed.• To ensure that staff are trained appropriately and are competent to do their jobs.• To issue Release for Supply certificate for listed products which are packed at GH• To manage and organize stability studies and validations.

Argentina

· Reporting to the Company Director, I was responsible to maintain the quality system within the organisation.· Performing general lab supervisory duties for Micro and Chemical departments.· Preparing technical reports, product specifications and analytical methods.· Planning and distribution of samples for analysis of raw materials, finished products, and stability samples.· Exceptional leadership skills utilized in managing teams of up to 6 quality technicians.· Writing, revising and approving Standard Operating Procedures / Equipment Operating procedures.· Preparing and maintenance of Working Standards with documents.· Creating and conducting GMP training for new employees.· Assisting with performance of Impact assessment and providing review and final approval of Investigation, Deviation and Corrective and Preventive Actions.· Evaluating Changed Controls - verifying implementation and closure.· Representing the department during audits, meetings.· Understanding the need to accomplish tasks with a sense of urgency.· Identifying and recruiting the right candidates with the required skill set and experience.· Working across different departments and functions. Reference available upon request

Argentina

Analytical Development Scientist· Evaluating analytical methods and procedures to determine how they might be improved.· Ensuring methods are developed under currents regulatory expectations.· Preparing analytical method development, validation, and test reports.· Performing investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.· Developing analytical methods appropriate for API’s and Finished Products involving the following factors:-Linearity-Range-Accuracy-Precision-Detection limit-Quantitation limit-Robustness-Recovery-Sample solution stability-Selectivity and Specificity.· Performing testing of finished products and stability samples.· Advance knowledge of HPLC.Reference available upon requestwww.sanofi.com.ar

Argentina

· Performing tests of starting materials, Intermediate, finished products and stability samples. Formulation types: Tablets, capsules, powders, liquids, lyophilized, cutaneous, suspensions, nasals, sprays, and patches.· Monitoring the microbiological quality of Environment (air monitoring) and water.· Performing TAMC, TYMC, and specific microorganisms test.· In the Microbiological department carried out Operation & Calibration of the instrument listed below:-Incubators and Refrigerators-Laminar flow cabinet-Microscope· In the Chemical department carried out Operation & Calibration of the instrument listed below:-HPLC (Waters alliance with Empower software, Shimadzu with Class VP and LC Solutions, Agilent with Openlab and Chemstation software and Merck Hitachi) & GC (Perkin Elmer)-UV-VIS Spectrophotometer-IR Spectrometer (Perkin Elmer)-Dissolution test apparatus (Hanson Research, Sotax, and Varian)-Polarimeter- Auto-titrators (Mettler Toledo & Karl Fischer apparatus) -Osmometer (Osmomat 050)· Participating in writing and revising SOPs, protocols and analytical techniques.Reference available upon requestwww.janssen.com

Argentina

Quality Control Analyst· Ensuring the quality of the incoming raw materials and finished products.· Preparing samples and chemicals for test.· Handling the following instruments:-Centrifuge-Magnetic stirrer-Vortex meter-Analytical balance-Micro pipettes-Rotatory shaker-Microscope-Hot air oven-Volumetric flasks-HPLC (Merck Hitachi)-Dissolution test apparatus.-SDS-PAGE· Maintaining the biological and chemical inventory list.· Using laboratory information system to analyze the results.· Ensuring laboratory is clean and safe and upkeep to assure it is well equipped with reagents, solutions, and supplies.· Ordering laboratory consumables.· Data entry to create certificates of analyses.· Knowledge of GMP’s, FDA, ISO regulations and quality standards.Reference available upon requestwww.merckgroup.com