The Manager Transport Validation is responsible to standardize the transport validation strategy across CSL Behring, in cooperation with Logistics Operations and Global Quality.
Perform qualification activities associated with new and existing transport systems and shipping processes as agreed upon with the Global Transport Management Centre of Excellence
Main Responsibilities and Accountabilities :
Prepare, implement and maintain departmental documentation for qualification activities and regulatory submissions
Coordinate qualification / validation planning with all stakeholders (Logistics, Service Providers, Customers)
Monitor external service providers that are contracted to CSLB and are involved in transport qualification activities (e.
g. logger placement and documentation).
Lead and / or participate in projects to identify, evaluate and implement new transport systems.
Carry out re-qualification activities according to internal procedures (risk-based) and maintain a valid qualification / validation status overview for all transport systems and processes.
Drive continuous improvement in processes of transport qualification / validation, ensure global cooperation and standardization.
Participate as subject matter expert in internal audits and external (e.g. TGA, FDA, RP, and Swiss Medic) regulatory inspection and customer audits, as requested.
Provide support for regulatory inspections, submission reviews and deviation investigation processes for transportation, dispatch packaging, and warehousing.
Maintain Material Specifications on transport systems used as according to Global Logistics procedures. Supports Global Logistics in Change Control System Operation and Reporting.
Position Qualifications and Experience Requirements :
Bachelor’s degree in a relevant business or science discipline or other qualifications with additional and relevant experience in a similar position
8+ years in logistics, quality, or manufacturing in the pharmaceutical industry
A minimum of 3 years experience in qualification and / or validation (supply chain area / transport validation a plus)
Solid experience in temperature mapping qualification and set-up or equivalent
Demonstrate a very good understanding of GMP requirements as well as solid know-how of supply chain in a GDP regulated environment
Strong experience in negotiation skills, with clients and suppliers; ability in successfully managing interfaces to other functions
Quality mindset in project management and implementation
Excellent English written and oral communication skills
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and / or diplomas in the original language.
Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.