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Quality control projects supervisor
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From m Abxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a un Quality Control Projects Supervisor (Bio) for our plant in León.General Responsibility Along with Quality Control Manager, implementation and maintenance of all biochemical activities related to new molecules.In 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.Specific ResponsibilitiesManage all analytical tasks for Quality Control Projects bio related to new projects such as:Projects follow up, using a suitable tool easy to followCollaborate with R&D in design, adjustment, implementation, transfer of analytical methodsCollaborate with MSAT in process validation protocols of new moleculesValidation and transfer activities of analytical methodsEnsure the new methods are corrected implemented in commercial departments and give support to them when neededManage of Reference standardsQPIs management related to QC projectsReview/manage changes in SOPs, Specifications, PTs, and applicable Training GuidesPrepare the technicians' shift schedule, if applicable, based on the department's needsAssist in the preparation/review of dossiers, BLA, and deficiency lettersControl and archive documentation related to qualification and validationOOS investigations and deviations managementCarry out activities for formation and training required for personnel from validation QC.Constantly keep themselves updated on progress of EU and USA standards so as to keep GMP compliance updated.Provide help in start-up, qualification/validation of equipment involved in QC labsManage change control documentation and CAPAProvide technical support during audit course (internal and external audits).Propose the acquisition of necessary resources (equipment, systems, personnel) for the tasks.Collaborate in the preparation of CAPEX, OPEX, and Head Count.Identification of needs and possibilities for improvement in the area.Manage and use computerized systems of general management (LIMS, SAP, Track Wise, etc.) so as to issue and control documents and analytical records of their responsibility.Requirements and personal skills Education: Bachelor of Sciences. Biology or biotechnology preferred Languages: Fluent Spanish and English. Experience (years/area): > 5 3 in a similar position. Specific Knowledge: Biochemical techniques. Validations. CMO. Investigations. Audits Travels: Available for sporadic travelling Personal skills: Management of work teams, organization skills, customer oriented, communication skills, proactivity and flexibility.m Abxience 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.
