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- ...Supports and performs Quality Risk Assessment · Ensure that all process changes are managed through appropriate change control procedure. · Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and...EmpfohlenTemporärPostdoc StelleSchichtarbeit
- ...sustained inspection readiness Own and continuously develop the Quality Management System (QMS), including deviations, CAPAs, change control, and data integrity Lead and govern GxP risk management, incident management, and compliance remediation activities Ensure...Empfohlen
- ..., method validations/verifications, investigations, and change controls - Contribute expert input to deviations, OOS/OOT assessments,... ...advantages - Good knowledge of sample preparation and contamination control for trace and ultra-trace analysis - Familiarity with ICH Q3D...EmpfohlenTemporär
- ...environments - Solid understanding of the pharmaceutical development process, both theoretical and practical - Experience with quality control standards - Familiarity with GMP guidelines; project management experience is a strong advantage - Proficient in English, both...EmpfohlenTemporär
- ...Kenntnisse in Siemens und/oder Rockwell fehlersicheren SPS gute Kenntnisse in Antriebstechnik (FU und Servoregler von Vorteil Motion Control) Vernetztes Denkvermögen (Flexibilität, Offenheit, strategische Weitsicht) Gute Deutschkenntnisse (mind. C1); sehr gute...EmpfohlenVollzeitFerienjob
- ...including change requests. Support the maintenance of Quality Risk Assessments (QRAs) . Contribute to defining and maintaining control strategies based on Critical Quality Attributes (CQAs) and, where applicable, Critical Process Parameters (CPPs) and Critical...EmpfohlenPostdoc Stelle
- ...standards. Provide data export or reports to systems users. Management of system operations in various systems in scope including: Control of system access and permissions, Perform change management activities, Liaise with users to resolve issues, Create reports based...Empfohlen
- ...learning, advanced analytics, data engineering/wrangling, database tools (SQL), cloud computing platforms (such as AWS), or version control (Git) is a plus Experience with clinical trial data standards (e.g. CDISC) and knowledge of data privacy regulations (e.g. GDPR)...Empfohlen