For our costumer a global pharmaceutical leader based in Zürich we are looking for an experienced
QC Manager (m/f)
In this position one has responsibility for operational, technical and compliance oversight for the Global Oncology External Supply Small Molecule, the Quality Operating Unit and Quality Control release and stability testing performed at external service provider for small molecule, recombinant biologics and cell therapy products as part of the global QC function
Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation leads, operational excellence leads, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.
- Create, maintain analytical documentations, e.g. protocols, specifications, methods, reports, etc.
- Act as deviation/Lab investigation owners, support Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help drive to closure in timely manner.
- Collates and reports out third party lab performance metrics.
- Provide analytical support to assigned products. Responsible for AR, APQR, regularoty filings, RTQs, etc of managed products.
- Supports the financial oversight of third party labs to assure budget requirements are met
- Develops testing plans and support method transfers as needed
- Manage stability study protocol development, execution, data analysis and reporting for products as designated
- BSc in Chemistry, Biology, or related scientific discipline.
- min 8 years experience in in the pharmaceutical industry and in a QA/QC laboratory environment
- good understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques.
- experience in analytical investigations, handling of OOS, OOT investigations.
- Experience in API and oral solid dosage is a plus.
- Experience in analytical laboratory, method execution, qualification and/or validation of small molecule or biologics assays.
- Experience in regulatory support, authoring dossier sections, respond to regulatory inquires.
- Strong communication and technical writing skills.
- Project management experience
- Knowledge of Laboratory Information Systems (LIMs).
Please apply online. For further information about the position, please contact your Kelly recruiter, Simone Mumbauer, PhD (+41 44 225 41 12).
About Kelly We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.