Sterilisation & Validation Lead – Flexible Pharma Quality
Ophtapharm AG
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Benefits offered by this job
Job summary
Ophtapharm AG is seeking a Sterilisation & Validation Expert to lead external sterilisation activities and validation tasks within the Qualification & Validation Team. You will ensure the highest quality, compliance, and patient safety across ophthalmic medicines.
Join a dynamic environment with significant influence on validation strategy and sterile manufacturing operations. Flexible working conditions and a strong pension scheme complement the role, with easy access by public transport and
Qualifications
- Strong knowledge of sterilisation technologies (Gamma, ETO, Steam) and validation methods.
- Experience in regulated pharmaceutical environments with GMP/quality focus.
- Confident communication in German and English.
- Structured, quality- and compliance-driven mindset.
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
Education
Job description
Ophtapharm AG is seeking a Sterilisation & Validation Expert to lead external sterilisation activities and validation tasks within the Qualification & Validation Team. You will ensure the highest quality, compliance, and patient safety across ophthalmic medicines.
Join a dynamic environment with significant influence on validation strategy and sterile manufacturing operations. Flexible working conditions and a strong pension scheme complement the role, with easy access by public transport and
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