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.

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.
• 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.

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.
• 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.

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.

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.

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.

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.