From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a QC CMO/CDMO Projects Supervisor for our plant in León.
General Responsibility
Along with the Quality Control Analytical Manager, manage from implementation to maintenance all activities related to CMO/CDMO new molecules. Suitable day-to-day organization within the area and designated technicians and analysts for CMO/CDMO Projects. In coordination with the Quality Control Manager, ensure method implementation in Quality Control.
Specific Responsibilities
* Plan, organize, and manage resources effectively to meet CMO/CDMO project timelines.
* CMO Projects follow up, using a suitable tool (i.e. projects, think cell…).
* Collaborate with clients in design, adjustment, implementation, transfer, and validation of analytical methods.
* Collaborate with MSAT in process validation protocols of new CMO molecules.
* Validation and transfer activities of analytical methods from CMO projects.
* Ensure the new methods are correctly implemented in QC commercial departments and give support to them when needed.
* Control and archive documentation related to qualification and validation.
* Oversee analytical method validation, verification, and transfer activities in accordance with regulatory guidelines and company standards.
* Ensure compliance with Compendial (USP, EP, JP) and ICH requirements for analytical methods.
* Assist in the preparation of quotations for projects.
* Assist in the preparation of budget related to CMO/CDMO projects.
* Suggest acquiring equipment and devices needed for new CMO projects.
* Management and execution of various stability studies according to GMP standards and procedures.
* Conduct investigations into complaints and deviations and report this to QA.
* Take care of corrective and preventive measures in the event of complaints and deviations.
* Manage change control documentation and CAPA.
* Participate in internal and external audits and regulatory inspections.
* Collaborate with Qualification and Validation personnel in design, adjustment, implementation, and qualification of equipment to be used.
* Carry out activities for training required for personnel from QC CMO Projects.
* Constantly keep updated on progress of EU and USA standards to maintain GMP compliance.
* Provide help in start-up, qualification/validation of equipment involved in QC labs.
* Provide technical support during audits (internal and external audits).
* Identify needs and possibilities of improvement in the area.
* Manage and use computerized systems of general management to issue and control documents and analytical records of their responsibility.
Requirements and Personal Skills
* Education: Bachelor of Sciences.
* Languages: Fluent Spanish and English.
* Experience: 5 years in the pharmaceutical/biotechnological industry in a similar role.
* Specific Knowledge: Biochemical, chemical, and immunochemical techniques. Validations. Tech transfer. CMO/CDMO projects.
* Travels: Available for sporadic traveling (1-2 a year).
* Personal skills: Management of work teams, organization skills, customer-oriented, communication skills, proactivity, and flexibility.
We offer a permanent contract to join a growing pharmaceutical company.
Benefits include:
* Life and accident insurance.
* Free company canteen.
* Free online training platform.
* Free online library.
* Social, physical, and emotional well-being platform.
mAbxience 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.
El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.es/empleo/138811574/ls-690-cmo-cdmo-projects-supervisor-leon/?utm_source=html
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