Sahra Maria Wissel

- Management of a global team, which is based in multiple sites - Definition & steering of the pharmaceutical change management process & of all activities related to master data compliance which is used for manufacturing, testing & packaging - Leading/collaboration in global projects concerning master data & processes - Personnel, budget planning and monitoring of the forecast - Worldwide communication with STADA production sites and contract manufacturers

Leading a global team of product compliance managers. Areas of expertise: Evaluation of pharmaceutical-technological questions related to product compliance in Global Quality. Authorization of manufacturing- and testing documents & validation reports with regard to compliance to regulatory documents. Assessment of deviations in manufacturing and testing of medicines and corrective and preventive measures. Worldwide communication & collaboration in projects.

Leading a team of specialists //Resource planning // Areas of expertise: Validation, Data Integrity, QRM, Change Control and Documentation // Ensuring compliance with the current regulations e.g. EU GMP, FDA Title 21 CFR, ICH and corporate policies // Driving departmental continuous improvement and lean projects // Presenting strategies and approaches in project meetings, audits and inspections

Acting as a Quality Assurance Subject Matter Expert (SME) for the Validation of Methods; Clean Rooms; Laboratory Equipment including Computerized Systems; Excelspreadsheets and Processes /// Ensuring compliance with the current regulations e.g. EU GMP, FDA Title 21 CFR, ICH and corporate policies // Preforming quality evaluations, assessing change control and deviations

Apprentice, Media Designer with the main stress on Media Engineering