Brežice, Brežice, Slovenia
• Maintain the oversight and knowledge for entire product packaging process performed on site and throughout the entire commercial lifecycle, since transfer from development to date. • Preparation of technological documentation, optimization of packaging technological processes and introduction of new technology into pharmaceutical production. • Collaboration with R&D department on developing product (especially considering packaging process, primary packaging material, stability samples preparation). • Responsible for technological transfer between sites. • Responsible for packaging part for newly launched products. • Lead / support project. • Responsible for initiation and coordination of changes on material / processes / product. • Intensive work on primary packaging material (documentation, testing) and cooperation with material suppliers. • Contribute to registration strategy and support registration activities. • Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples. • Support Validation Lead and Experts to assess need and plan validations. • Support with APQR review. • Lead / support root cause investigation of process failures / primary packaging material issues, initiate and lead product improvement projects, involving cross-functional teams. • Responsible for providing compliance with legislation, external GxP regulations, internal regulations and recommendations of the company. • Working in GMP environment.
• Field survey. • Database editing. • Administrative work.