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Qualified Person & Narcotics 20%

Astrasana Holding AG

Employment type
Part-time
Location
Kloten
Company
Astrasana Holding AG, Gerbegasse 2, 8302 Kloten
First posted
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Qualified Person (QP) & 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 related to narcotics (purchasing, storage, processing, distribution)
Control of stocks, execution and evaluation of inventories as well as creation of reports in MESA
Inspection and release of narcotics deliveries as well as ensuring correct storage and traceability
Maintenance and updating of internal Standard Operating Procedures (SOPs) in the field of narcotics
Contact person for authorities during inspections and audits
Collaboration on 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 areas (ETH, Uni or FH)
Experience as QP in Switzerland and knowledge of regulatory requirements (HMG, BetmG, BetmKV)
Ideally qualification as a qualified person according to Swissmedic requirements
Experience in a GMP- or GDP-regulated environment
Very precise and structured way of working
Good German language skills in speaking and writing, English skills are an advantage jpid7c8a355jm jit0831jm jiy26jm

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Posted 7 weeks ago

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