Head of quality operations

Reporting to the CEO I am responsible for the manufacturing site of the company, with dedicated premises for a wide diversity of (mostly) prescription medicines, including antibiotics for oral and parenteral administration. The portfolio is distributed in 4 continents, mainly in a growing number of countries across Europe and in Latin America. Under my leadership there are the following functional áreas: Production, QA, QC, Planning & Logistics, Engineering & Maintenance, Health Safety & Environment. 

I was the responsible person at Atral for the management and development of the internal portfolio, either for the internal new drug development plan and for the in-licensing deals, in alignment with the strategic plan of the company.  

I was responsible for the physical, chemical and microbiological analysis of all incoming materials (API's, excipients, packaging materials, printed materials), IPC, drug product, either for release as well as for the stability studies (SDP and SMP). 

I was responsible for the physical, chemical and microbiological analysis of all incoming materials (API's, excipients, packaging materials, printed materials), IPC, drug product, either for release as well as for the stability studies (SDP and SMP). 

I was appointed by the Board of Administration of Atral as QP of the JV company formed by Atral and a pharmaceutical Indian company for a new business related to the treatment of additctive behaviours.

Certification by the QP and batch release for the market – annex 16; Revision to annex 13 of GMP; The role of the QP in the release of experimental medicines for clinical trials.

Definitions of Wholesale Distribution and Applicable Laws; guidelines 2013/C 343/1, of 5 November 2013 (personnel, facilities and equipment,
documentation, operations, complaints, devolutions, counterfeit medicines and product recall, outsourced activities, self-inspections, transportation and specific provisions for brokers).

History of antibiotics; beta-lactams, glycopeptides and phosphomycin, antibiotics inhibitors of protein synthesis, quinolones, sulphamides and anti-TB; MoA, resistance, MRSA, VRE, ESBL, CTX-M, pharmacology, adverse events and clinical uses.

International regulations, strategies and tactics to conducting an audit and issuing the related report.

DMAI2C methodology (Process Excellence) for the continuous improvement of processes; statistical tools for measurement (ANOVA, paired t-test, regression, correlation), analysis of results, rules for prioritization (brainstorming, SIPOC, priority matrix, FMEA, CTQ), process improvement, innovation, design of experiments

Fundamentals of management; pharmaceutical marketing; marketing research; identification of business opportunities; management of human resources; competitive and SWOT analysis; strategic marketing; legislation and regulations in the pharmaceutical market; forecasting methodologies; marketing plan.