Senior GCP QA Auditor - Spain

Descripción del trabajo From Mabxience, a company specialized in the development and manufacture of biosimilar medicines, we are incorporating a MSAT medical devices technician for our plant in León.

Global responsibilities

The medical device specialist will act as drug device combination expert, including planning and coordination of the implementation of medical devices manufacturing processes for new molecules under development in external CDMOs. Collaborate with mAbxience development team and third companies in device development stages as well as regulatory submissions.

Specific responsibilities

Search and selection of new technologies, suppliers and CDMOs for the development and assembly of medical devices.

Collaborate in generation of medical devices Design History File (DHF) and related documentation.

Authoring of tech transfer protocols and reports for medical device manufacturing in selected CDMO.

Scientific support during medical device development, assembly process tech transfer and validation. Deviation root cause and impact assessment, as well as CAPAs.

Coordination of medical device assembly process implementation and validation at CDMO.

Generation of risk assessments, process description, bill of materials, manufacturing procedures and sampling plans compliant with regulatory standards and guidelines.

Support of regulatory submission process, including SME input and / or revision of relevant dossier sections and participation in regulatory agency interactions.

Lead the evaluation and implementation of process improvements and scale-ups. Support in regulatory variation procedures.

Requirements and personal skills

Education : university degree oriented to biotechnology, biochemistry, chemical engineering or the like.

Languages : fluent English. Knowledge of other languages (mainly Spanish) will be an asset.

Experience (years / area) : ≥5 years of experience in Operations, R&D, MSAT in development and manufacturing of medical devices, mainly prefilled syringes (PFS) coupled with needle safety devices (NSD) and autoinjectors (AI).

Travels : Open to travel.

Personal skills : experience in project management and scale up to industrial manufacturing, work in GMP environment, DHF generation and regulatory filling (ICH, EMA and FDA requirements), tech transfer, process validation.

We offer a permanent contract to join a growing pharmaceutical company.

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.

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