Roberto Pani Email & Phone Number

Bern Und Umgebung

Switzerland

Cadempino

Management of QA- and subcontractor activities for the Swiss market (complaints, changes, evaluation of PQR, subcontractor qualification, audits, Quality Agreements, ...) and part-time Data Protection Officier.

Bedano

Responsible for the Management, Qualification, Calibration and Maintenance of Machinery, Equipments, Utilities, Buildings. Leading maintenance and warehouses departments. Responsible for Health, Safety and Environment (HSE) and for handling of dangerous substances, for emissions and for wastes. Perform internal audits and participate to customers and authorities inspections. Key achievements: - reducing costs of waste disposal of 50%- reducing purchasing coasts of maintenance department of 15%- better quantification of solvents emissions with significant tax savings

Ticino

Planning, material purchasing and construction supervision for the renovation of a 200 years old historic house.

Zofingen

Supplier qualification and auditing. Performing internal audits. Organize, host and follow-up of customer audits. Evaluating the documentation and performing physical audits to manufacturers and sub-contractors. Preparation of authorities' inspections.

Manno

Performing physical audits to API manufacturers, development of pharmaceutical oral dosage forms, head of stability group, cleaning validation, analytical validation. Supporting the regulatory affairs department with technical documentation and quality overall summary for registration dossier.Successful technology transfer for the manufacture and analysis of industrial scale batches of a low doses drug by a subcontractor.Set-up and management of a program for ICH- and on-going stability for pilot and industrial scale batches.

Manno

Team leader, pharmaceutical development of oral solid forms, preparation of technical documentation for the Regulatory Affairs department, assessment of DMF, validation reports, modules of dossier and Quality Overall Summary. Production of pilot scale batches for clinical studies according to the cGMP. Contact with customers for answering the technical questions and the Deficency Letters.

Manno

QA Activities (Qualification, Validation, VMP, CAPA, internal and external audits, training, batch records, SOP, deviations)

Bioggio

QA activities, QC, development effervescent tablets

Ligornetto

QA for a laboratory of pharmaceutical and medical analysis, GMP, ISO 9001, SOP, performing some environmental, food, medical and pharmaceutical analysis

Zug

Contribution with the creation of the emission inventory and with the assessment of environmental performance reports. Keep contacts with Industry and trade for the control and quantification of the emissions and with the responsible of air protection of the other cantons. Organization of a training day for painters

Doctor Of Philosophy (Phd), Anorganische Analytische Chemie

Diplom, Anorganische Chemie, 5.5