Job Description

Die Ophtapharm AG ist eine FDA/EU-GMP zertifizierte Produzentin im Pharmabereich (Ophthalmika). An unserem Produktionsstandort in Hettlingen bei Winterthur werden fur internationale Markte qualitativ hochstehende Produkte wie Augentropfen, -salben und -gele aseptisch produziert, abgefullt 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:
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