Team Lead QA Compliance

at  Tillotts Pharma

To be located at our HQ in Rheinfelden, we are looking for a

• Lead and mentor the QA Compliance team
• Ensure readiness for regulatory inspections and customer audits, coordination and preparation of HA inspections
• Plan and perform internal self-inspections and external GDP audits (e.g. distributors, carriers, Affiliates, etc.)
• Supplier selection and qualification to support Tillotts business
• Primary contact point for Tillotts affiliates as responsible QA / Organize & lead the Global Quality Meeting
• Management of GDP Quality Agreements with partners and affiliates
• Establish, maintain, and support a Quality Risk Management approach and Quality Risk Management tools
• Ensure suitainable management of Tillotts eQMS MasterControl
• Optimize the pharmaceutical quality systems, assessing and improving procedures, systems, and quality tools
• Perform shipment releases (incl. document check, specification check, and artwork check where applicable), ensure on-time releases by the QA Compliance team
• Author, review, and approve QA documents (e.g. Policies, SOPs, Work Instructions)
• Perform GxP, system, and process trainings and support of all Tillotts`s departments in GxP topics
• Support the organization with monitoring of compliance quality process and GxP standards
• Keep track of new regulatory guidelines and implement them together with the QA Team at Tillotts / Lead the guideline committee to review the impact of new regulatory guidelines on the organization
• Responsible for the safety and health of the QA Compliance team in the workplace /Responsible for the implementation of the HSE regulations for the QA Compliance team