Sterilisation & Validation Expert - Quality & Compliance

Ophtapharm, a Sentiss Company; Zürich; On-site; CHF 110,000 - 160,000; Full time

Benefits offered by this job

Flexible working conditions

Pension scheme

Free parking

Job summary

Ophtapharm AG, part of Sentiss, seeks a Qualification & Validation expert to own sterilisation processes and validation activities. You will work with internal stakeholders and external partners to uphold quality and patient safety.

In this role you will lead external sterilisation activities, prepare validation documentation, and support SIP and bulk product validation. You will influence strategy and ensure regulatory compliance in a dynamic environment.

Qualifications

• Knowledge of sterilisation technologies (Gamma, ETO, Steam).
• Experience with sterilisation validation in regulated environments.
• Background in aseptic pharmaceutical manufacturing.

Responsibilities

• Lead external sterilisation activities for active ingredients, excipients, and packaging materials.
• Prepare, review, and maintain sterilisation validation documentation.
• Support SIP and bulk product validation activities.
• Manage filter validation programs and ensure regulatory compliance.
• Build strong partnerships with external sterilisation service providers.

Skills

Sterilisation tech

Sterilisation validation

Aseptic manufacturing

German language

English language

Job description

Ophtapharm AG, part of Sentiss, seeks a Qualification & Validation expert to own sterilisation processes and validation activities. You will work with internal stakeholders and external partners to uphold quality and patient safety.

In this role you will lead external sterilisation activities, prepare validation documentation, and support SIP and bulk product validation. You will influence strategy and ensure regulatory compliance in a dynamic environment.