Batch Release Manager (m/w) 100 %

Key information

Publication date:28 May 2025
Workload:100%
Contract type:Unlimited employment
Place of work:Hettlingen CH

Job summary

Ophtapharm AG is a certified pharmaceutical producer specializing in ophthalmics. Join a dynamic team offering growth opportunities and a supportive work environment.

Tasks

Classify and assess deviations, ensuring timely investigations.
Approve critical GMP documents and ensure compliance.
Support audits, manage KPIs, and assist in quality reviews.

Skills

PhD or MSc in Pharmacy, Biology, Microbiology, or Chemistry required.
5+ years experience in GMP-regulated environments needed.
Fluency in German and English (C1 level) essential.

Is this helpful?

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.

Batch Release Manager (m/w) 100 %

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 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)

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

Contact

Ophtapharm AG
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Batch Release Manager (m/w) 100 %

Key information

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Skills

Batch Release Manager (m/w) 100 %

Contact

Ophtapharm AG

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