компания "bayer" position: local quality manager external manufacturing сн location: moscow responsibilities: ensure readiness of bayer local/global third -party manufacturers including performance monitoring providing quality oversight and assuring compliance and implementation of cgmp and other relevant quality regulations at these sites. accountable for analytical activities at third party manufacturers during product transfers, new product development and projects, leading analytical method validation /cleaning validation/ stability strategies/ and other related quality aspects with evolving projects accountable for quality oversight and products / processes capability on all bayer formulations manufactured at the local cmos within scope of responsibilities. participate and contribute into cmo lifecycle (selection, qualification and phase-out) support strategy deployment and business needs contributing, as q em representative, to relevant decision boards. ensure processes and standards are followed within quality external manufacturing in order to better support business needs with regards to suppliers and products from a qa standpoint. steer the supplier and product evaluation management processes for q em managed local suppliers from a quality perspective participate in operational excellence and product supply system initiatives and tools with the objective to continuous improve. accountable to establish and maintain a quality risk management culture for projects. review and approval of related risk assessments and control strategies. liaise with innovation & development for analytical transfers or validation in new product developments (npds). support the manufacturing / packaging process and cleaning validation of transferred or new products developed and manufactured at contract manufacturers (cmos) located mainly in middle east and africa regions. review process validation protocols and reports in collaboration with bayer technical management functions. determine and establish, together with technical management, bulk holding time for each manufacturing step, as needed. accountable for determination and implementation of capa at contract manufacturers (cmos) together with effectiveness check to ensure continuous improvement of bayer product and process. connect and partner with global team members to drive continuous improvement of business processes within impacting countries. support strategic goal of optimizing the cmo network within area of scope evaluate, from a quality standpoint, change controls at cmos related to transfers and projects. important for us: years of experience 5+ previous experience with local cmos leading projects from quality perspective within external manufacturing higher education the “must have” and “preferred” skills set and experience we are looking for must have : english fluency and another language is a plus . demonstrated learning agility leadership within a matrix organization diverse quality background is a plus technical background 2-3 years preferred pmo opex mindset can work in a dynamic environment / with challenges life values : drives results business insights collaborates courage manage ambiguity we offer: career in the sustainable international company; monthly salary and annual bonus; meal allowance, corporate mobile coverage; health and life insurance; 35 days paid vacation; corporate learning and development program; corporate reward and recognition program.
Адрес
Москва