Derks & Derks Detachering
Temporary position for 6 months at a pharmaceutical company
- a diverse job at a global pharmaceutical company
- an interesting job because of the international contacts
- a temporary contract for 6 months, with the possibility to extend
Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for an Associate QMS Manager.
As an Associate QMS Manager you will work under limited supervision or completely independent. In this role it will be your responsibility to implement operational plans for your region. You will support global audits and inspections and deliver on process improvement. You will also be involved at process compliance matters as well as KPI management and Metrics. Delivering support to the management and maintenance of controlled safety documents like SOP are also included in your tasks. You will collaborate with relevant GPV and non GPV partners on a global level. Next to that you will participate in projects related to Audit and Inspection management and Process Improvement. As well as Controlled Document management and/or Compliance management. You will be representing QMS and taking ownership for specific tasks and deliverables. You will make sure they are to ensure oversight as well as compliant with all applicable worldwide pharmacovigilance regulations and internal and external KPIs. In this role you report to the Global Lead QMS or Process Improvement Team Lead.
- Minimum BA/BS.
- At least 4 years within a pharmaceutical, biotechnology or related industry.
- Minimum 2 years’ of experience in Pharmacovigilance (e.g. in case processing), Regulatory affairs or Safety Quality Assurance, preferably experience in support of the safety quality systems.
- Understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations.
- Experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle.
- Good understanding of PV and Clinical Research processes, and other processes making up the PV system.
- including the interfaces between these processes.
- Very good understanding of PV, data management and adverse event reporting and processing.
- Excellent oral and written communication skills, ability to interact with all levels of personnel.
- Must be able to communicate in English (active and passive), other languages considered an asset.
- Computer literacy (including Microsoft Office, Access and Project).
Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-065-DD, to Sandra van Putten: firstname.lastname@example.org. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.