Description
Our client is a very succesfull pharmaceutical company focuses on providing innovative pharmaceutical products in the therapeutic areas of bacterial infections, fungal infections and oncology, targeting the medical challenge of rising resistance and nonresponse to current treatment options. On their behalf I am currently looking for a:Stability & QC Release Consultant
Responsibilities:
- Contribute substantially to assigning and monitoring stability studies and release testing analytics under GMP at external partners.
- Organise the corresponding work orders, protocols, and reports. Especially for the late stage and commercial projects provide all stability reporting needed to abide to current regulations.
- Interface to QA and procure compliant analytical data packages at the external analytical laboratories.
- Support compilation of regulatory documentation.
- The candidate is instrumental in assigning/monitoring external stability studies and QC testing under GMP.
- According to the respective needs of the project and in close collaboration with QA, provide compliant protocols, data packages, and reports for all studies assigned to external partners.
Task(s):
- Be instrumental in assigning and monitoring of all work orders regarding stability studies for development and commercial products, and batch release testing (intermediates, API, DP) at external partners according to the respective project's need.
- Provide well-designed stability protocols in accordance with development or commercial phase and specific aspects for each project.
- Perform tracking of released batches and stability testing results, including the statistical treatment of data, if required.
- For late-stage development and for commercial projects perform statistical/trending evaluations needed for marketed products.
- Interface to Analytical R&D: Inform organisation (e.g. AD, QA) as early as possible on expected OOT/OOS results; Incorporate appropriate conditions for e.g. forced degradation, in-use studies, compatibility studies; collaborate with AD and AR e.g. for correct peak alignment at external labs.
- Interface to QA: Provide stability reporting; procure compliant data packages for each study; support team in making regular stability statements.
- Interface to Regulatory Affairs: Contribute stability and batch results to regulatory documentation;
Competence(s):
- Chemist/pharmacist with 5+ years of experience in managing all aspects of stability studies and QC testing, including marketed products (PQR/ APR).
- Good communication skills (ideally knowing matrix organizations/interfaces), excellent English written and spoken.
- Experience in working with external partners.
Function emphasis:
After an internal reorganisation of the Quality Unit, all QC activities regarding the assignment and monitoring of external stability and batch release testing under GMP is assigned to the Analytics department. During and after this transition, a consultancy is foreseen to substantially contribute to managing this additional CMC workload. This function will initially take over managing all stability and release testing activities and create a workload list of still open items.
After an initial training and settling-in period of ca. three months mostly on site, she/he will act as an interface between external labs and Analytics, which will ensure adequate stability studies/reporting and batch tracking. This work can be done mostly remote with regular face-to-face meetings at the headquarter , or the respective contract partner.The contract duraton is guaranteed for min one year with hight possibility for an extension with approx 25 working hours a week.
About me:
I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word including your hourly rate expectation for immediate consideration.
You can reach me on or at