Description de l'emploi
Responsible for the management of QMC projects requiring specific scientific experience and skills in the health products sector, in line with the requirements of Benelux and European regulations.
Quality & Compliance services:
- Obtain & maintain perfect knowledge of applicable legislation and main quality guidelines
- Stay up to date with scientific developments relevant for the portfolio of the clients.
- Contribute to the management of the development and maintenance of PLx’s Customers quality
- Assist in audits and inspections (customers, authorities)
- Participate in working meetings with clients to solve the client’s issues
- Be actively involved in internal meetings with Pharmalex project teams. Acting Pro-actively in those meetings
- Participate in audits or diagnosis of dossiers
- Submit PSUR/PSUSA
- Control packaging and labelling texts
- Participate in archiving activities
- Comply with relevant quality procedures
- You will actively participate to tasks corresponding with your abilities, including activities related to other Value Delivery Centres (VDCs) (Pharmacovigilance, DCS, REG), if asked by management.
Key Performance Indicators
- Attainment of yearly goals according to performance evaluation process
- Completion of work assignments in accordance with internal departmental guidelines and quality procedures Adherence to schedules
- Client satisfaction
- Project KPIs
Key Decisions made by a QMC Specialist
- Decision on suitability of quality approaches in consultation with project management
- Decision regarding projects planning, budgeting and organization in consultation with project management
- Advisor to clients on QMC procedures and requirements in consultation with project management
Critical qualifications, experience, ‘know-how’ and skills
- Successful completion of Pharmacist’s diploma or a scientific Master’s degree, or in some cases an adequate bachelor’s degree
- 1 to 3 years of professional experience and project management experience
- Good Knowledge of English on top of Dutch. French is a plus.
- Good knowledge of European regulatory requirements for quality systems within medicinal products
- Distinctly strong service orientation
- Content-related experience in several relevant areas of QMC
- Ability to manage one or several projects with limited guidance
- Autonomous approach to work, flexibility and dedication
- Diplomacy, ability to communicate and fit in an international and multicultural environment
- Strong sense of responsibility, organizational skills and intrinsic motivation
- Good knowledge of the MS-Office package
- Professional communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.