Christopher Mamo Email & Phone Number

Malta

Malta

Various GMP rules in Quality Assurance and acting as a Qualified Person (QP) and Responsible Pharmacist (RP) on behalf of clients or in own capacity in various industries:- Primary Healthcare - Hospital - Pharmaceuticals- Nutraceuticals - Medical Cannabis - Wholesale and Distribution of Medicinals - Execution of External Audits on a variety of supply and service providers - Coordinating and managing ex-EU licensing activities - Design and Validation of… Show more Various GMP rules in Quality Assurance and acting as a Qualified Person (QP) and Responsible Pharmacist (RP) on behalf of clients or in own capacity in various industries:- Primary Healthcare - Hospital - Pharmaceuticals- Nutraceuticals - Medical Cannabis - Wholesale and Distribution of Medicinals - Execution of External Audits on a variety of supply and service providers - Coordinating and managing ex-EU licensing activities - Design and Validation of Software in compliance to 21CFR Part 11 and EU Annex 11 - Global Supply Chain Management (initial procurement, registration and supply)- Setup of brand new pharmaceutical facilities (concept design phases to licensing and operation phase) - Gap Analysis and remediation for suppliers of various materials and services for new companies wishing to enter the pharmaceutical market Show less

Malta

Malta

Malta

Direct responsibility for all aspects concerning the GMP Status of the Company, including upkeep of Licenses, QP Activities including Batch Certification and Release, Quality Assurance, Quality Control, Third Parties, Regulatory Affairs, and Validation. Project Co/Leader responsible for the implementation and achievement of: - Startup setup of Quality Management System; - Maintenance of Importation License through renewal inspections; - Attainment of license of the assembly… Show more Direct responsibility for all aspects concerning the GMP Status of the Company, including upkeep of Licenses, QP Activities including Batch Certification and Release, Quality Assurance, Quality Control, Third Parties, Regulatory Affairs, and Validation. Project Co/Leader responsible for the implementation and achievement of: - Startup setup of Quality Management System; - Maintenance of Importation License through renewal inspections; - Attainment of license of the assembly of solid dosage forms (June 2013);- Attainment of license for the manufacture of solid dosage forms (January 2014);- Attainment of license for the manufacture and importation of investigational medicinal products (January 2014); - Attainment of registration with ex-European ministries of Health; - Steered company in conversion of parts of the facility to handle highly-specialized product ranges; and- Successful launches of various products for various markets on patex (day-one launches). Lead Auditor of subcontractors as part of implementation of ongoing projects, including but not limited to: - Finished Dosage Form Manufacturers in India and Arab States;- Manufacturers of Excipients and Packaging Materials;- Contract Laboratories; - Holders of MIAs having various scopes, permitting subcontracting of activities. In addition to and concurrently with the above projects, continuously active in Batch Certification and Release of products imported from Third Countries. Show less

Malta

Organisation and coordination of the various elements forming the QMS, including but not limited to Audits, Internal and Regulatory Compliance, QA Systems, Product Management Systems, Training and Release functions, whilst attaining the most effective and efficient deployment of human, equipment and material resources within a given budget. This is achieved whilst ensuring compliance on a consistent basis, and through adherence to group and company policies & procedures, quality standards, EH&S… Show more Organisation and coordination of the various elements forming the QMS, including but not limited to Audits, Internal and Regulatory Compliance, QA Systems, Product Management Systems, Training and Release functions, whilst attaining the most effective and efficient deployment of human, equipment and material resources within a given budget. This is achieved whilst ensuring compliance on a consistent basis, and through adherence to group and company policies & procedures, quality standards, EH&S regulations as well as the relevant International GMP Standards, as applicable to pharmaceuticals destined for human use. Show less

Malta

Co-Ordination of QA Activities, with direct responsibility for a number of activities including among others Deviation Management, CAPA Management, Internal Auditing, Product Quality Reviews, Training (including delivery of cGMP Course) and Batch Documentation Management.Design and setup of Quality Systems including the above and others. Participation at all levels of Client and Regulatory Audits received by the Company, and conduct of External Audits on GMP Service Providers.

Malta

All aspects of Quality Assurance, including Internal Auditing, External Auditing, Management of the Change Control System, Preparation of training requirements and delivery of cGMP Courses, Documentation Management, Approval of Suppliers, Validation (except Process Validation and Analytical Method Validation), Drafting of Applicable CTD Sections, etc..

Malta

Preparation of SOPs, Specifications, Analytical Methods and other forms of documentation; Management of documentation; Management of the training system; Management of pharmacopoeial compliance.

Malta

Malta

B.Pharm.

Sciences