Validation Lead - Clinical Pharmacology Unit - Belgium
- We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
- Employees of our Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
- Our company is one of the most innovative pharmaceutical companies in the world.
- Our research and development center develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
- Validation strategy definition (Validation Master Plan);
- Project planning for validation of computerized systems;
- Sets up requirement definitions in co-operation with the system users;
- Creates and maintains SOPs, work instructions, guidelines for system use;
- Coordinates and coaches validation and qualification activities;
- Qualification and validation execution;
- Writes qualification and validation documentation;
- Involved in QA and Q&C;
- User support during validation;
- Coding & Mapping agreements definition and documentation;
- Configuration agreements;
- Validation of Data Management functions (cf. above);
- Process definition and documentation;
- Is the subject-matter expert, responsible for compliance with the internal quality system. Provides direction and actively contributes to developing, improving and implementing Standard Operating Procedures and Working Instructions. Notifies any violation or deviation to the immediate supervisor or appropriate authority.
Other Accountabilities and Duties
- Back-up for System Administrator;
- Internet Compliance Authority (ICA) CPU;
- Interacts with many levels and functions within the organization; internally in the CPU as well as externally, such as Integrated Data Management, QM/QA, and A&TD;
- Interacts with the IM organizations responsible for applications (Pharma R&D IT) and infrastructure (ITS);
- Connects with external suppliers of related instruments and software to monitor the technical evolutions in this area;
- Actively contributes to the development and maintenance of specific working instructions and SOPs;
- Develops productive partnerships with business partners and vendors;
- Credo: liaises with all the members of the Department and makes a positive contribution towards team spirit in collaboration with the Credo Team.
- Observes and promotes all regulatory requirements as defined per applicable regulations rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority;
- Complies with all training requirements necessary to perform the duties of the job;
- Assures that assigned (on call) staff complies with the training requirements to perform the specific tasks.
Responsibility for Others
- Coaching of key users, business owner, and system administrator in validation activities
- A Master’s and/or Bachelor’s degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics
- Advanced course work in technical systems plus continued education in technical disciplines is preferred
- Additional certification is a plus
Minimal Work Experience
- Minimal 8-10 years’ working experience in a regulated environment
Minimal Technical Skills, Knowledge and Qualifications
- Good working knowledge of the ICH-GCP guidelines and other relevant regulations and regulatory guidelines
- Good knowledge of project management
- Able to apply technical/professional knowledge to the execution of clinical trials
- Fluency in written and spoken English
- Proficiency in written and spoken Dutch
- Able to cope with administrative tasks
- Extensive knowledge of computerized system validation, preferably experience with company PRD validation methodology
- Extensive knowledge of 21 CFR Part 11
- Knowledge of process modeling techniques
- Insight/experience in validation of EDC systems
- Experience in qualification of medical devices and lab equipment
- Knowledge of testing methodologies
Minimal Non-Technical Competencies and Skills
- Strong organizational, operational and management skills
- Strong written, verbal and interpersonal communication skills
- Able to prioritize and multi-task
- Able to establish and maintain effective working relationships
- Good accuracy and attention to detail
- Results driven
- Pro-active and creative in identifying and solving problems
- Interested in early clinical research, practical medical work and contact with healthy volunteers and patients
- Strong analytical and problem-solving skills
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow change management procedures and internal guidelines
Minimal Other Requirements
- Willingness and ability to be flexible with work hours and when necessary to work outside office hours to facilitate protocol requirements and/or to guarantee the safety of the volunteers or patients.
- This position is located in the Clinical Pharmacology Unit in Merksem.
- As an employee we consider you as our most valuable asset.
- We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
- Through e-university, on the job training, various projects and programs, we ensure your personal growth.
- Our benefits make sure we care for you and your family now and in the future.