GMP Specialist* | Pharma

GMP Specialist | Pharma Full-time Wasserburg am Inn 38 hours 30 days of vacation For the first time, limited to 31.12.2027 MEGGLE – The brand with the Kleeblatt Our diverse range of butter specialities delights “Gourmeggles” worldwide. With our milk dry products we are partners of the food processing industry, with our lactose even leading in the pharmaceutical industry. Founded over 135 years ago as a small cheese mill, MEGGLE is one of the most renowned producers of dairy products in Europe. At the time as today, MEGGLE stands for the highest quality. Over generations and cultures, more than 1,000 employees at the Wasserburg site are constantly developing and are celebrating success together. We are the team MEGGLE! MEGGLE welcomes all people.

In this position, you are responsible for the compliance and further development of quality systems to ensure GMP compliance in the product range of pharmaceutical auxiliaries.

Responsibility for the implementation of relevant guidelines and further development of quality systems to ensure GMP compliance Representation of the Department, Quality Oversight and Coordination of Implementation Activities in Development Projects Monitoring, supervision and processing of operational quality aspects, including Batch Record Review, CAPA Management, Change Control, Deviation Control Ensuring and further developing the validation strategy (validation master plan), support of validation projects and stability studies Creation, review and update of relevant documentation and reports, including DMF, customer information, management report, PQR, quality guidelines, SOPs Assessment and processing of complaints and accompanying derivation of measures and action plans for quality improvement on the basis of Cause Analysis Implementation and guarantee of customer and certification audits (ISO 9001, EXCiPACT) and co-ordinative responsibility for the processing of identified deviations Responsible organisation and implementation of self-inspections and qualification of suppliers

Successfully completed scientific or technical studies (e.g. pharmacy, pharmaceutical technology, process engineering, food technology) or comparable training Multiannual experience in quality assurance, development or production in the pharmaceutical environment or their suppliers Expertise in common GMP regulations (including EU GMP guidelines, ICH Q7) with regard to quality assurance and good manufacturing practice Knowledge of relevant standards in the field of excipients (EXCiPACT, IPEC-PQG GMP Guide) Systematic, careful and targeted working and very good analytical skills High level of commitment, initiative and organisational talent Representative communication and problem-solving competence Secure handling of MS-Office and SAP Very good knowledge of German and English

We offer a safe workplace with versatile tasks. We accompany you on your career path and offer you individual training opportunities.

Thanks to our cooperation with famPLUS, you will receive support in all situations of life – whether in nursing advice or child care. In addition, you can benefit from numerous financial advantages: For a healthy and active lifestyle we grant your EGYM Wellpass and your JobBike leasing.

Our corporate culture is characterised by cohesion - so we regularly organize employee events, promotions and team building activities to strengthen cooperation. And the best thing: Our tasty products can be purchased at the discounted sales! JOBV1_EN