descripción del trabajo

pFrom mAbxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a un strongQuality Control Projects Supervisor (Bio) /strong for our plant in León. /ppbr/ppstrongGeneral Responsibility /strong /ppAlong with Quality Control Manager, implementation and maintenance of all biochemical activities related to new molecules. /ppIn coordination with Quality Control Manager, suitable day-to-day organization within area and designated technicians and analysts. Besides creation and maintenance of a documentation system for qualification and validation protocols related to the area employee is responsible of. /ppbr/ppstrongSpecific Responsibilities /strong /pulliManage all analytical tasks for Quality Control Projects bio related to new projects such as: /liliProjects follow up, using a suitable tool easy to follow /liliCollaborate with RD in design, adjustment, implementation, transfer of analytical methods /liliCollaborate with MSAT in process validation protocols of new molecules /liliValidation and transfer activities of analytical methods /liliEnsure the new methods are corrected implemented in commercial departments and give support to them when needed /liliManage of Reference standards /liliQPIs management related to QC projects /liliReview/manage changes in SOPs, Specifications, PTs, and applicable Training Guides /liliPrepare the technicians' shift schedule, if applicable, based on the department's needs /liliAssist in the preparation/review of dossiers, BLA, and deficiency letters /liliControl and archive documentation related to qualification and validation /liliOOS investigations and deviations management /liliCarry out activities for formation and training required for personnel from validation QC. /liliConstantly keep themselves updated on progress of EU and USA standards so as to keep GMP compliance updated. /liliProvide help in start-up, qualification/validation of equipment involved in QC labs /liliManage change control documentation and CAPA /liliProvide technical support during audit course (internal and external audits). /liliPropose the acquisition of necessary resources (equipment, systems, personnel) for the tasks. /liliCollaborate in the preparation of CAPEX, OPEX, and Head Count. /liliIdentification of needs and possibilities for improvement in the area. /liliManage and use computerized systems of general management (LIMS, SAP, TrackWise, etc.) so as to issue and control documents and analytical records of their responsibility. /li /ulpbr/ppstrongRequirements and personal skills /strong /pullistrongEducation: /strong Bachelor of Sciences. Biology or biotechnology preferred /lilistrongLanguages: /strongFluent Spanish and English. /lilistrongExperience (years/area): /strong 5 years in the pharmaceutical / biotechnological industry. 3 in a similar position. /lilistrongSpecific Knowledge: /strongBiochemical techniques. Validations. CMO. Investigations. Audits /lilistrongTravels: /strong Available for sporadic travelling /lilistrongPersonal skills: /strongManagement of work teams, organization skills, customer oriented, communication skills, proactivity and flexibility. /li /ulpbr/ppemmAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance. /em /p