Quality Control Projects Supervisor (Bio)

mAbxience; Valladolid; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A biosimilar medicines company in Valladolid is seeking a Quality Control Projects Supervisor. This role involves managing analytical tasks for new projects, collaborating with R&D for method implementation, and ensuring compliance with regulations. The ideal candidate will have over 5 years of experience in the pharmaceutical industry, strong skills in biochemical techniques, and fluency in both Spanish and English. This is an opportunity to contribute to innovative projects in a dynamic environment.

Formación

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

Responsabilidades

• Manage all analytical tasks for Quality Control Projects.
• Collaborate with R&D in design and implementation of analytical methods.
• Ensure new methods are correctly implemented in commercial departments.

Conocimientos

Biochemical techniques

Management of work teams

Communication skills

Proactivity

Organization skills

Customer oriented

Educación

Bachelor of Sciences (Biology or biotechnology preferred)

Descripción del empleo

Quality Control Projects Supervisor (Bio)

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.

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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.

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).

Requirements and Personal Skills

• Education: Bachelor of Sciences (Biology or biotechnology preferred).
• Languages: Fluent Spanish and English.
• Experience: >5 years in the pharmaceutical / biotechnological industry; >3 years 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.