Ophtapharm AG
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
8442 Hettlingen CH
Riethofstrasse 1
8442 Hettlingen CH
Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 13 23.
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 13 23.