Quality Control Projects Supervisor (Bio)

mAbxience; Madrid; Presencial; EUR 45.000 - 55.000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company in Spain is seeking a Quality Control Projects Supervisor. The role involves managing analytical tasks for quality control projects and ensuring compliance with regulatory standards. The ideal candidate has a Bachelor's degree in Biological Sciences or Biotechnology, with at least 5 years in the pharmaceutical industry and fluency in Spanish and English. This position offers opportunities for improvement and collaboration across various departments.

Formación

• 5 years in the pharmaceutical or biotechnological industry.
• 3 years in a similar position.
• Fluent in Spanish and English.

Responsabilidades

• Implement and maintain biochemical activities related to new molecules.
• Manage analytical tasks for Quality Control Projects.
• Ensure compliance with EU and USA standards.

Conocimientos

Management of work teams

Organization skills

Customer oriented

Communication skills

Proactivity

Flexibility

Educación

Bachelor of Sciences, Biology or biotechnology

Herramientas

LIMS

SAP

TrackWise

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 traveling.

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.