Responsible person

Inspection of all received batches of pharmaceutical products pursuant to the relevant articles of valid Act on Pharmaceuticals, principles off good manufacturing practice and good distribution practice determined by the valis Slovak legislation, valid instructions from the State Institute for Drug Control, valid registration documentation of these preparations. The extent of the inspection is determined by the internal regulations.

Inspection of the collection, evaluation and archiving of data documenting the conditions during the transport and distribution of pharmaceutical products

Responsibility for the Register of Movement of all released batches.

Responsibility for the recall process of pharmaceutical products

Dealing with complaints regarding the quality of pharmaceuticals and responsibility for decision-making on corrective measures and their execution in entitled cases.

Processing of detected discrepancies in respect with the compliance with the GMP/GDP standards

Processing of change management in respect with the compliance with the GMP/GDP standards

Responsibility for the introduction and maintenance of quality system within Roche Slovensko s.r.o as well as within contracted warehouses where Roche products are stored.

Acts as a point of contact for local Health Authorities in matters arising from the professional job content.

Prepares and evaluates, revises and updates, approves Standard Operational Procedures (SOP) of Roche Slovensko s.r.o., ensures SOP adherence by performing internal and external audits of quality controll at workplaces of Roche Slovensko s.r.o, in contracted warehouses and others contracted service providers in relationship with GMP/GDP activities.

Provides reports of medicinal supplies, consumption and export to ŠÚKL and MZSR int he extent determined by the valid Slovak legislation and ŠÚKL and MZSR instructions.

Preparation and execution of training of Roche employees and of employees at contracted warehouses participating in the distribution and other activities related to GMP/GDP in the extent determined by the valid Slovak legislation and ŠÚKL instructions

Obligation to immediately inform the company management in writing on any facts concerning the non-compliance of procedures with the GMP/GDP

Cooperation with profesionally related departments of Roche Basel, Roche Grenzach and Roche Slovensko s.r.o

Within one business day of awareness of adverse event and special situation inform Drug safety colleagues as specified in Adverse event training.

We offer:
- interesting working in a young dynamic team
- competitive salary and transparent remuneration system
- benefits package (13th salary, 5 vacation days in addition, contribution to pension plan, 5 sick days, sick leave compensation)
- systematic education and career opportunities
- background of succesfull foreign original company