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Die Ophtapharm AG ist eine FDA/EU-GMP zertifizierte Produzentin im Pharmabereich (Ophthalmika). An unserem Produktionsstandort in Hettlingen bei Winterthur werden für internationale Märkte qualitativ hochstehende Produkte wie Augentropfen, -salben und -gele aseptisch produziert, abgefüllt und verpackt.
To strengthen our quality assurance team, we are looking for a Batch Release Manager to join us as soon as possible.
Ihre Aufgaben Classification and final assessment of deviations as well as coordination of activities in the context of processing deviations, including ensuring the timely completion of investigations
Approve critical GMP documents
Support in root cause analysis and definition of meaningful CAPAs
Deputy Qualified Person (QP) and Deputy fachtechnisch verantwortliche Person (FvP), playing a key role in ensuring product quality
Batch Release as deputy Qualified Person/ Fachtechnisch verantwortliche Person FvP
Ensure compliance with the relevant cGMP & regulatory requirements
Provide clear updates on release status, risks and issues to stakeholders
Proactively identify capability gaps and define the path to building new capabilities within Quality
Collect, monitor and report Key Performance Indicators (KPIs)
Support during Health Authority Inspections and Customer Audits
Perform Supplier Audits
Support creation and review of annual Product Quality Reviews & Management Reviews
Ihr Profil PhD or MSc in Pharmacy, Biology, Microbiology or Chemistry
5+ years of experience in GMP-regulated environments
Profound knowledge of Swiss, EU, and US Good Manufacturing Practice Regulations
Logical thinker and natural leader, comfortable networking and connecting people
Excellent communication abilities
Fluent in German and English (C1 level)
Strong facilitation and organisation abilities
Ihre Vorteile Dynamic work environment and career opportunities
In our company culture we prefer the personnel "You
Parking lots for free and close connection to public transportation within walking distance
Possibility of partial home office (depending on the role)
Arbeitsort Ophtapharm AG
Riethofstrasse 1
8442 Hettlingen CH
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