Beschreibung

In this role, you will be at the forefront of training and documentation, ensuring that operators and scientists are well-equipped to meet quality and business objectives. Your day-to-day responsibilities will involve developing training programs, conducting assessments, and supporting manufacturing activities in compliance with cGMP standards.

Anforderungen

• •Studies in Pharmaceutical Technology, Chemistry, or Pharmacy
• •Experience in MES recipe authoring, preferably in Emerson Syncade
• •Process knowledge in sterile drug product
• •Knowledge of DeltaV
• •Familiarity with regulated environment, cGMP, 21CRF part 11, and validation requirements
• •Proficiency in German and English
• •Familiarity with GMP requirements, quality procedures, and SOP execution
• •Good interpersonal skills and interaction with various interfaces
• •Structured, focused, and well-organized working demeanor
• •Motivation and problem-solving attitude

Aufgaben

• •Act as a change agent in the Drug Product department
• •Conduct training activities for operators and scientists
• •Align training programs with quality and business goals
• •Develop training strategies and materials for various levels
• •Provide training in classroom and shopfloor settings
• •Assess trainees’ competencies and qualifications
• •Write and adapt department-specific SOPs
• •Execute manufacturing activities according to cGMP guidelines
• •Evaluate test results and troubleshoot manufacturing equipment
• •Prepare and review electronic batch records
• •Review production documentation and manage deviations
• •Implement change requests and CAPAs to maintain GMP standards

Tools & Technologien