Responsible Person for Technical Affairs & Narcotics 20%
- Employment type
- Part-time
- Location
- Kloten
- Company
- Astrasana Holding AG, Gerbegasse 2, 8302 Kloten
- First posted
Responsible Person for Technical Affairs (FvP) & Narcotics (m/f/d) 20%
Main tasks:
Responsibility for technical management according to the Therapeutic Products Act (HMG) and the Narcotics Act (BetmG)
Ensuring compliance with legal requirements (Swissmedic, Therapeutic Products Ordinance, Narcotics Control Ordinance)
Monitoring and documentation of all activities in connection with narcotics (purchasing, storage, processing, distribution)
Control of stocks, implementation and evaluation of inventories as well as creation of reports in MESA
Inspection and release of narcotic 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, Uni or FH)
Experience as FVP in Switzerland and knowledge of regulatory requirements (HMG, BetmG, BetmKV)
Ideally qualification as a responsible person for technical affairs according to Swissmedic requirements
Experience in a GMP or GDP regulated environment
Very precise and structured way of working
Good German skills in spoken and written, English skills an advantage jpid7c8a355jm jit0831jm jiy26jm
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Posted today