Technically Responsible Person (TRP) & Narcotics (m/f) 20%

About the job

Main Tasks:

• Responsibility for the technical management in accordance with the Therapeutic Products Act (HMG) and Narcotics Act (BetmG)

• Ensuring compliance with legal requirements (Swissmedic, Therapeutic Products Ordinance, Narcotics Control Ordinance)

• Monitoring and documenting all activities related to narcotics (procurement, storage, processing, distribution)

• Stock control, conducting and evaluating inventories as well as preparing reports in MESA

• Checking and releasing narcotics deliveries as well as ensuring correct storage and traceability

• Support and updating of internal standard operating procedures (SOPs) in the area of narcotics

• Contact person for authorities during inspections and audits

• Participation in quality management tasks (e.g. CAPA, deviations, change control)

• Training of employees in handling narcotics

Requirements:

• Completed studies in pharmacy, chemistry, biology or related life science fields (ETH, university or university of applied sciences)

• Experience as TRP in Switzerland and knowledge of regulatory requirements (HMG, BetmG, BetmKV)

• Ideally qualification as a technically responsible person according to Swissmedic requirements

• Experience in GMP- or GDP-regulated environments

• Very precise and structured way of working

• Good German skills in spoken and written form, English skills advantageous