Activities:
· Manages, prepares and maintains the process related to microbiological and chemical methods and related validations according to the internal procedures and national and international regulations.
· Identifies, investigates and assesses bottlenecks and deviations in the performance of methods, validations and procedures (for both internal and outsourced processes) and their connection to applicable legislation/regulations and regulatory files.
· Acts as contact person for all internal and external parties involved in the procurement and/or outsourcing, answers questions and provides explanations.
· Coordinates changes, monitors the implementation of actions arising from the changes.
· Lead for Quality Agreements related to QC.
· Lead for QC of Prothya (global) multidisciplinary projects.
o Coordinates the (global) multidisciplinary projects by assessing impact, time and resources needed from QC.
o Conducting assessments of impacted QC processes against the external requirements and legislation/regulations.
o Managing all actions needed from QC to implement the project in a timely manner.
The Global QC Support Department:
The Global QC Support department works in synergy with the QC Operations departments in the Netherlands and Belgium. The Global QC Support department is part of the Quality Unit and consists of four teams, Method Validation, Equipment Qualification, Stability & QC Master Data and Projects. Within Global QC Support the Projects team is responsible for all QC related changes, projects, quality agreements and external contact management.
Your Skills:
· Preferably HBO with at least 5 years’ experience in a Pharmaceutical cGMP laboratory environment (QC or R&D)
· Familiar with Pharmaceutical QC testing conform Pharmacopoeia monographs (Ph. Eur and USP)
· Broad knowledge in monitoring changes in legislation and regulations and assessing or applicability to the organization, like FDA, EMA and ICH
· Broad experience in writing and reviewing of QC documents and assessments for both analytical chemical and microbiological tests
· Experience in MasterControl, SAP, is preferred
· Project management experience is preferred;
· Meticulousness and sense of safety and hygiene;
· Good communication and negotiation skills to operate in multidisciplinary teams;
· Stress resistant, flexible, independent, pro-active and hands-on mentality;
· Fluent in English both written and spoken;
· You want to grow, create impact and get the most out of yourself and your colleagues.
We Offer:
You are part of a motivated team of Projects Specialists where you can work on your personal development, ambitions and personal choices. Your job will be full of challenges, variation and possibilities to extend your skills and knowledge. You will be appreciated for who you are and what you do in an inspiring, inclusive and respectful working environment with great colleagues.
