Productivity and quality inspired leader with +9 years experienced managing teams focused on the compliance with global regulatory standards. Core competences include:- Excellent communication and interpersonal skills- Well organized, disciplined, able to work with minimal supervision- In depth knowledge of WHO, EU and FDA regulations, applied to production, cGMP, validation, calibration, and qualification Keywords: Qualification, Validation, Cleaning Validation, Aseptic, cGMP, Safety, Regulatory Compliance, Hazop, HACCP, DQ, IQ, OQ, PQ, FAT, SAT, URS, Clean Room, ISO14644, FDA, Media Fill, Pharmaceutical, KPI, Analytical Method Validation, Sterility, Cold Chain, Biotech, Biopharmaceutical, CAPA, Production ManagmentSpecialties: Proven track record in the pharmaceutical management in the following areas:- Production- Biopharmaceutical- Premises, systems and equipment qualification, commissioning and start up- Pharmaceutical processes validation/ Aseptic process validation- Cleaning validation- Analytical methods validation- Sterilization design and validation (dry heat and moist heat)- KPI implementation and management- Constitute and develop multi-disciplinary teams