We are currently searching for a QC Project Lead for one of our clients, a global bio-pharmaceutical company located in Switzerland.
As a QC Project Lead, you'll be a key player collaborating closely with analytical laboratories, program management, process development, production, and quality assurance departments. Your role involves technical and administrative leadership in complex, long-term Drug Product projects. Acting as the primary on-site QC interface for our customers, you'll ensure project delivery aligns with agreed objectives. This position requires excellent planning and management skills for timely and cost-effective processing of orders, adapting to changing customer requirements.
Key Responsibilities:
- Establish and maintain strong customer relationships.
- Prepare and supervise production batches, including sample logistics.
- Process change requests and deviations under GMP guidelines.
- Supervise customer audits and inspections by authorities.
- Calculate and monitor QC costs in the project.
More Specific Duties:
- Act as the technical and administrative QC project lead in complex, long-term DP projects.
- Serve as the primary on-site QC interface for customers, ensuring project delivery aligns with objectives.
- Anticipate innovations in the field and manage the implementation of new technologies.
- Support QC Deviation and CAPA processes, reviewing and assessing investigation reports.
- Provide input to program management regarding QC capabilities and requirements.
- Lead tech transfer activities related to QC, including generating master transfer plans and method-specific assay transfer protocols.
- Coordinate with testing sites across locations and external service providers.
Key Requirements:
- Doctoral or master's degree in biotechnology or related field with significant biopharmaceutical experience.
- Practical experience and scientific expertise in DP relevant areas.
- Leadership skills to motivate and develop team members.
- Fluent in English; German proficiency is a plus.
- Experience with method validation and technology transfer.
- Strong team orientation, structured, solution-oriented, and well-organized working attitude.
- Knowledge of SAP and TrackWise systems is a plus.
Drug Product Background:
- Multiple years of experience in aseptic processing for Drug Product and associated installations.
- Expertise in media fill/aseptic process simulation.
- Background in environmental monitoring with microbiological expertise.
- Familiarity with visual inspection/CCIT of Drug Product.
- Experience with moist heat and dry heat sterilization processes.
For further information about this position, please apply with your CV.
*Please note, only those with the right to work in Switzerland can apply!
