DUTIES AND RESPONSIBILITIES
Regulatory / Compliance
- Maintain a thorough understanding of applicable SOPs, cGMP requirements, and company policies relevant to assigned activities.
- Ensure full compliance with the Quality Management System and regulatory requirements within Pharmaceutical Sciences, Aptuit Verona.
- Perform all activities in accordance with site safety procedures and guidelines.
- Author, review, and maintain Standard Operating Procedures (SOPs) and related documentation.
- Manage equipment-related deviations, investigations, CAPAs, and Change Controls, ensuring timely completion and effectiveness.
- Support the implementation and follow-up of corrective and preventive actions.
- Maintain training records up to date and complete all required training activities in a timely manner.
Technical / Scientific
- Support the qualification, maintenance, calibration, administration, and lifecycle management of laboratory equipment and computerized systems.
- Define business requirements and provide technical expertise for equipment qualification, maintenance, and performance monitoring activities.
- Coordinate and manage third-party suppliers involved in equipment maintenance, qualification, and laboratory support services.
- Develop and support business continuity plans for critical laboratory equipment and processes.
- Plan, execute, review, and document qualification, requalification, and maintenance activities.
- Author and review qualification protocols, reports, risk assessments, and technical documentation.
- Ensure maintenance schedules are effectively managed and completed according to plan.
- Troubleshoot equipment and configuration issues, providing timely user support to minimize laboratory downtime.
- Investigate equipment incidents, identify root causes, assess operational impact, and support implementation of corrective actions.
- Define and oversee GMP requirements related to laboratory instrumentation and computerized systems.
- Manage the lifecycle of SOPs and controlled documents related to equipment management.
- Support internal audits, client audits, and regulatory inspections, acting as a subject matter expert for equipment-related topics.
Administrative / General
- Foster clear and effective communication with colleagues, stakeholders, and management.
- Keep the supervisor informed of progress, priorities, issues, and achievements.
- Collaborate effectively within cross-functional teams and contribute positively to team objectives.
- Demonstrate flexibility and adaptability in managing changing priorities and workloads.
- Exhibit strong organizational and planning skills to ensure efficient execution of assigned activities.
- Apply sound problem-solving and decision-making skills to resolve technical and operational issues.
- Promote a culture of continuous improvement, compliance, and operational excellence.
Requirements:
- Experience with GC-MS, LC-MS systems and laboratory equipment used for physical analysis and characterization is considered an advantage.
- Working experience in GMP environment.
- English minimum low-intermediate English
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
EN: In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
IT: In compliance with fundamental ethical and professional principles and with Legislative Decree 198/2006, Evotec is an Equal Opportunity Employer committed to fostering a safe, diverse, and inclusive workplace built on mutual respect. We provide equal employment opportunities to all qualified candidates and employees based on their skills, experience, and professional qualifications. In line with our ethical and professional principles, all employment-related decisions, including recruitment and selection processes, are made fairly and without any form of discrimination. All qualified candidates will be considered for employment regardless of race, color, sex, age, disability, genetic information, gender expression, gender identity, nationality, religion, sexual orientation, or any other characteristic protected under applicable law.
