offres d'emplois ICH

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 team in Hettlingen, we are looking for a

at the earliest possible date

Manager Quality Control (m/w) 100 %

Ihre Aufgaben

Lead and manage the QC department, including Analytical Chemistry, and working closely with Microbiology and In-Process Control teams
Ensure that all analytical testing is in compliance with cGMP, FDA regulations (21 CFR parts 210/211), and relevant Swiss and EU regulations for sterile drug manufacturing
Oversee the sampling, testing and release of raw materials, in-process samples, and finished sterile ophthalmic products, ensuring timely and accurate results
Develop, implement, and maintain robust analytical methods and testing procedures
Drive continuous improvement initiatives within the QC laboratory to enhance efficiency, compliance, and data integrity
Initiating and promoting automation and digitalization of processes
Manage and mentor QC team members; provide technical and regulatory guidance, training, and performance management
Represent your area of responsibility during Health Authority Inspections (e.g., FDA, Swissmedic) and Customer Audits
Collaborate cross-functionally with Quality Assurance, Manufacturing, Regulatory Affairs, and R&D to support new product development and commercialization
Lead investigations, root cause analysis, and CAPA for out-of-specification (OOX) results and other quality issues
Ensure effective management of laboratory equipment, qualification, calibration, and maintenance in accordance with cGMP
Maintain and ensure adherence to a comprehensive stability program for products marketed in the US
Oversee preparation, review, and approval of QC-related SOPs, protocols, reports, and specifications

Ihr Profil

Advanced degree in Pharmacy, Chemistry, or related scientific field
Minimum 10 years of experience in Quality Control, with at least 5 years in a leadership role within sterile pharmaceutical manufacturing
Strong knowledge of FDA cGMP, USP, ICH guidelines, and EU GMP for sterile products
Experience working in or with facilities exporting to the US pharmaceutical market; prior involvement in successful FDA inspections is a must
Hands-on experience with modern analytical instrumentation (e.g., HPLC, GC, UV-VIS, FTIR)
Demonstrated leadership, decision-making, and project management skills
Curious and interested in innovation and improvement
Excellent communication skills as a point of contact across departments and functions
Fluent in German & English

Ihre Vorteile

Dynamic environment with development opportunities
Possibility of partially working remotely (20% max)
Free parking and public transport within walking distance
Above-average social benefits

Arbeitsort

Ophtapharm AG
Riethofstrasse 1
8442Hettlingen CH

Haben Sie Fragen?
HR Hettlingen, Human Resources, beantwortet Ihnen diese gerne. Tel: +41 52 304 12 36.

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