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Batch Release Manager (m/w) 100 %

Ophtapharm AG
Riethofstrasse 1, 8442 Hettlingen CH
2J
Postuler en ligne
  • 28.05.2025
  • 100%
  • Employé
  • Durée indéterminée

Batch Release Manager (m/w) 100 %




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

Batch Release Manager (m/w) 100 %

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 defining 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 the public transportation in walking distance
  • Possibility of partial home office (depending on the role)

Arbeitsort
Ophtapharm AG
Riethofstrasse 1
8442Hettlingen CH


Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 13 23.