Sterilisation & Validation Expert

pbAt Ophtapharm AG, we manufacture sterile ophthalmic medicines that help patients around the world protect and improve their vision. As an FDA and EU-GMP certified pharmaceutical company, quality is at the heart of everything we do. /b /ppAs part of our Qualification Validation Team within the Quality Department, you will be the go-to expert for sterilisation processes and validation activities. Working closely with internal stakeholders and external partners, you will help ensure the highest standards of product quality, compliance, and patient safety. /ph3Your Role /h3ulliLead external sterilisation activities for active ingredients, excipients, and packaging materials. /liliPrepare, review, and maintain sterilisation validation documentation. /liliSupport SIP and bulk product validation activities. /liliManage filter validation programs and ensure regulatory compliance. /liliBuild strong partnerships with external sterilisation service providers. /li /ulh3Your Profile /h3ulliStrong knowledge of sterilisation technologies such as Gamma, ETO, and Steam. /liliExperience with sterilisation validation in a regulated environment. /liliBackground in aseptic pharmaceutical manufacturing. /liliConfident communication skills in German and English. /liliStructured and solution-oriented mindset with a strong focus on quality and compliance. /li /ulh3What you can expect /h3ulliA specialist role where your expertise directly contributes to product quality, compliance, and patient safety. /liliThe opportunity to shape and further develop validation and sterilisation processes. /liliA key expert role with significant influence on validation strategy and sterile manufacturing operations. /liliA dynamic environment with short decision-making paths and room for new ideas. /liliFlexible working conditions, an attractive pension scheme, and convenient access by public transport or free parking. /li /ulh3For recruitment agencies: /h3pThank you for your interest. We are not engaging external support for this role. /p #J-18808-Ljbffr