Peter Jozsef Nagy

Cooperation with and facilitation of the tasks of the Head of Release and the release team. • Batch records: review and release • Release Document Registry System: specification, testing and introduction • Preparation of PQRs according to the annual plan • Process development: automation of PQR documentation process by MS Excel / VBA: planning, preparation, validation • Design and setting up KPIs for the team: data collection, identification, definition, implementation • Training: entry/annual GMP trainer

Cooperation with and facilitation of the tasks of the QP and the release team. • Batch records: review, feedback, facilitation of decisions / measures • Training: entry/annual GMP trainer for the whole company • Preparation of PQRs according to the annual plan, statistical process data analysis, comparison with facts, process understanding, conclusion and escalation • Customer Audits / Inspections: participation as SME

Cooperation / facilitation of the tasks of the QMgr and the QA team. • SOPs: Preparation and Review of key QMS SOPs • Support: Changes, Validation, Qualification and Documentation • Investigation: Customer / Supplier Complaints, Deviations, • Cooperation / Supervision: CAPA measures • Review: PQRs, MBRs • Contacting / reporting: DE, JP • Training: GMP trainer • CSV: GxP Equipment and utility systems of production and laboratory IT systems • Audits / Inspections: coordination of the team, supplier audit

Cooperation with and facilitation of the tasks of the Head of QA. • Batch records: review and release for dispatch (fine chemicals and APIs). Release for Customer complaints: questionnaires, manage and follow-up, Complaints • Documentation of measures: supplier evaluation, mock recalls, change control, deviations, non-conformances, OOS & CAPA management. • Quality related procedures: preparation and review of key QMS SOPs

Coordination, preparation and review of Product Quality Reviews on tablet packaging and manufacturing processes in the global supply chain. • Data collection: locally and throughout the global supply chain • Review: data analysis by Excel / Minitab • Communication / decision preparation: For the partner departments and globally • Training: training and mentoring the PQR team

Coordination and Review: API process and cleaning validations, equipment qualifications • Preparation and review: SOPs, protocols, reports, summaries, statistical trend analyses for PQRs according to the annual plan • Cooperation and Support: coordination, communication, administration, training, gathering data and reporting • Process development project: Increasing throughput of owned process • Participation in other projects: commissioning, process risk assessment • Setting up KPIs for the field

Laboratory-scale preparative synthetic chemical production, production of intermediates for combinatorial chemical syntheses