Overview
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.
In the role of Batch Release Manager, you will ensure regulatory compliance und product integrity for sterile medicinal products to strengthen our quality assurance department. You will act as deputy Qualified Person (QP) und deputy Fachtechnisch verantwortliche Person FvP.
Position
Batch Release Manager (m / w) 100 %
Responsibilities
* 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
* Support in Change Control assessments and Complaint investigations
* 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
Qualifications
* 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
Benefits
* 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
8442 Hettlingen CH
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