Quality Control Projects Supervisor (Bio) en León

Descripción del empleo

From mAbxience, 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 Responsibilities

• Manage all analytical tasks for Quality Control Projects bio related to new projects such as:
• Projects follow up, using a suitable tool easy to follow
• Collaborate with R&D in design, adjustment, implementation, transfer of analytical methods
• Collaborate with MSAT in process validation protocols of new molecules
• Validation and transfer activities of analytical methods
• Ensure the new methods are corrected implemented in commercial departments and give support to them when needed
• Manage of Reference standards
• QPIs management related to QC projects
• Review/manage changes in SOPs, Specifications, PTs, and applicable Training Guides
• Prepare the technicians' shift schedule, if applicable, based on the department's needs
• Assist in the preparation/review of dossiers, BLA, and deficiency letters
• Control and archive documentation related to qualification and validation
• OOS investigations and deviations management
• Carry 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 labs
• Manage change control documentation and CAPA
• Provide 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, TrackWise, 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 years in the pharmaceutical / biotechnological industry. >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.

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.

Información extra

Status

Activa

Estudios requeridos

E.S.O

Localización

León

Tipo de contrato

Trabajo estudiantes

Publicado el

27-11-2025

Carnet de conducir

No

Vehículo

No

Carta de motivación

No

Idiomas

Español