Manager QA / EU QP Deputy in Rheinfelden bei TILLOTTS PHARMA AG

If you want to use your proven skills within an innovative pharma specialty company, this could be the perfect opportunity for you!
In this role you will act as EU QP deputy of Tillotts Pharma GmbH for the products manufactured by Tillotts Pharma AG or CMOs.

• Decide on the release of finished products to the European Economic Area (EEA) market for sale (“Batch Release”) by certification (e.g. according to AMG, §19) independently of management
• Implement and maintain a Quality Management System for TP GmbH and provide support for efficient and compliant pharmaceutical operations based on GMP guidelines
• Ensure that the products are in accordance with the product registration and the current EU legislation covering Medicinal Products for Human Use, Good Manufacturing Practice (GMP) as well as Good Distribution Practice (GDP)
• Support Tillotts Pharma GmbH in setting up and maintaining a Quality Management System (QMS)
• Support all relevant QA processes performed in Rheinfelden TP AG (e.g. release, OOS, deviation management, change management, audit, Self Inspection, PQR, QMS documentation) according to Swiss and European regulations
• Quality Oversight of contract manufacturers (DS,DP)
• Give directives for all processes impacting the quality of the products
• Perform/Participate in external audits, self-inspection and HA inspections
• Assist in the company supplier audit program
• Prepare, review and update Product Quality Reviews (PQR) according to GMP
• Review and update SMF and QMS documentation (SOP, Policy)
• Coordination of quality relevant relations with suppliers and customers (deviation, OOS, Change Control, Quality Agreements)
• Review and approval of related quality events (deviation,CC,OOS)
• Provide QA support on projects when required (i.e. launches, product transfer, manufacturing improvement)
• Constantly drive to deliver high standards of GMP
• Prepare, review and approve Master Formula

• Pharmacist with relevant experience
• Registered EU QP or Eligible as EU QP according to AMG §15
• Experience acting as EU QP in Pharmaceutical/biological manufacturing businesses
• Work according to EU GxP Guideline as well as Swiss and German law
• GMP/ GDP Experience
• At least 3 years’ experience in Quality Assurance GMP/GDP in the pharmaceutical/biological industry
• Fluency in English and German (in written and spoken)
• Flexible and structured team player with the ability to work in a fast-paced, rapidly changing environment and a problem-solving approach
• Ability to work under pressure and prioritize tasks
• Open-minded for new ideas and suggestions
• Solution-oriented with entrepreneurial mind-set
• Strong interpersonal and communication skills
• Willingness to travel (5%)

• A great opportunity to work in a diverse environment where you can learn, develop your existing competences, and learn new skills
• A good working environment where you can directly affect our business. You will be in the front line working with various departments
• A highly flexible workplace where we respect Work-Life balance and where open communication and great team spirit is highly valued

Tillotts Pharma (www.tillotts.com) is a fast-growing international specialty Pharma company located outside of Basel employing over 300 employees in Switzerland and abroad. We are dedicated to the development, in/out-licensing, acquisitions and marketing of innovative pharmaceutical products in the field of gastroenterology and specialty products. We successfully market our own as well as in-licensed and acquired products in over 65 countries through our affiliates as well as a network of carefully chosen licensing- and marketing partners. We are engaged in close collaborations with pharmaceutical research centers and universities. Tillotts group is reporting in IFRS and consolidating different affiliates in Europe.

Yolanda Perez is looking forward to receiving your complete application