Beschreibung
QUALITY CONTROL MANAGERDuration: 10 Months
Location: Zurich, Switzerland
OBJECTIVES/PURPOSE
- This position has responsibility for operational, technical and compliance oversight for Global Oncology External Supply Small Molecule (OncESSM) Quality Operating Unit (OpU) Quality Control (QC) release and stability testing performed at external service provider (contract test labs and manufacturing organizations; CTLs and CMOs) for small molecule, recombinant biologics and cell therapy products as part of the global QC function
- Create, maintain analytical documentations, e.g. protocols, specifications, methods, reports, etc.
- Directly liases with, and manages, relationships with external testing partners to ensure continuity of testing, investigation and resolution of unexpected results and represents the company in interactions with providers
- Compiles and monitors performance metrics and supports continuous improvement of activities within QC organization
- Support analytical and manufacturing investigations of unexpected results to identify root cause and defines and implements corrective or preventive actions
- Works closely with OncESSM Quality OpU leadership to support the forecast of future spend, monitoring variances, and support improvements with financial benefit.
- Provides support to data analysis, data entry, purchase order creation/reconciliation and financial oversight of third party labs in Europe and other regions as required by the third party lab locations.
- Supports compliance of testing network through participation in external provider audits, data review and data integrity verification, development of quality agreements and assures execution to requirements.
- Support regulatory filing and product APQR.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor's Degree in Chemistry, Biology, or related scientific discipline.
- Min 8 + years experience in in the pharmaceutical industry and/or QA/QC laboratory environment.
- Must have good understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques. Must have 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.
- Cross functional and matrix management experience.
- Awareness of financial processes.
- Project management experience
- General understanding of applicable regulations and guidances.
- Strong proficiency in Microsoft tools, especially Word and Excel.
- Knowledge of Laboratory Information Systems (LIMs).
Keywords: QC, Quality Control, QC Manager, Quality Control Manager, Small Molecule, Oncology, API, Manufacturing, Data Analysis, Project Coordination, Project Management, Quality Systems, Validation, Document Revisions, Operational Leads, Investigation, GMP, Pharmaceuticals, Zurich, Zürich
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.