Real Staffing is currently looking for an Analytical Project Manager for one its clients based in Walloon Brabant (long term project)
Within the framework of commercial products and more particularly pharmaceutical drug substance & drug products (i.e. chemical based compounds), you will act as Project Manager in the Analytical & Quality Control (QC) testing field to support Analytical Product Owners (APO) by performing the following tasks:
- Providing analytical testing expertise to support commercial products activities;
- Contributing to the Life Cycle Management of commercial products through project management as team member and/or as project leader, based on the scope of the project;
- Maintaining the portfolio of analytical methods, by publishing and updating analytical methods and associated validation according to the company requirements, by managing change control according to the sop and by ensuring follow-up with internal and external QC;
- Maintaining the specifications portfolio, by publishing and updating specifications according to requirements, by managing change control according to the company sop and by ensuring follow-up with internal and external QC;
- Maintaining the portfolio of official monographs in Pharmacopoeias (mainly EP and USP);
- Maintaining the stability portfolio for products in scope by reviewing and publishing stability reports, by consolidating the portfolio of studies within the organization and by collecting required analytical information for stability studies;
- Maintaining the overall view on the QC testing network by mapping the network of commercial products in scope, by collecting all analytical related information and documents (QC testing sites, external QC testing sites, methods, specifications, validation reports, …) and by ensuring the repatriation of relevant documents from external to the company.
- Implementing and maintaining Global specifications and Global methods for products in scope.
- You have project management skills with demonstrated capacity for managing projects autonomously;
- You are able to manage a broad range of stakeholders with different constraints;
- Key technical expertise: chromatography (HPLC, UPLC and GC), detection techniques (UV/Vis, Mass Spectrometry); dissolution techniques;
- Good understanding of European, US, Japan and Chinese regulations, including pharmacopoeias;
- You have a proven track record in the CMC field, either in Analytical Development or Quality Control (not only lab experience);
- You have a degree in Analytical Chemistry
- French: fluent
- English: fluent
You have detailed understanding of regulatory and GMP quality constraints
You have good organizational skills.
You demonstrate excellent interpersonal, verbal, and written communication skills
Are you interested in discussing the role further? Please feel free to reach out