MNLK IMMUNOTHERAPEUTICS UNIPESSOAL LDAQuality

Senior Specialist Drug Product and Device (GxP)

PTonsitesenior

via Personio

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About this role

Job Purpose The Senior Specialist Drug Product and Device (GxP) provides comprehensive support to Technical Operations and perform essential oversight of Good Manufacturing Pratice (GMP) compliance for Drug Product (DP) and Device vendors. They will manage all Quality-related issues, oversee CAPAs, Change Controls, and handle GMP-related Temperature Excursions and Technical Complaints, collaborating effectively with the rest of the MoonLake Quality team, the Technical Operations team and consultants (where necessary). This role is responsible for the receipt, assessment, investigation, documentation, and closure of technical complaints in accordance with GxP regulations (including GMP, GCP, and GDP, as applicable).…

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What we'd score you on

reqspace match rubric

Five dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.

Skills match

For this role: go, rest, gcp

Level fit

This role is senior-level. We check your trajectory against it.

Domain experience

Your work in the role's domain matters more than your years total. We weight recent and direct experience.

Recency

A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.

Location fit

This role is based in PT. We weight your proximity and willingness to relocate.

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Skills in this role

Pulled from the job description. These are the keywords we'll weight when scoring your fit.

gorestgcp

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