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Sr Associate, Quality Engineering

Are you a self-driven and motivated team-player who takes ownership and responsibility of your assignments? Then you might be our new colleague!

Job Description

We are currently looking for an experienced person with a technical background and experience from working in a GMP environment to join our Quality Engineering team in Hillerød. This team is part of the Quality Assurance Operations department for Large Scale Manufacturing. As the Quality Engineering team is an integrated part of the change and improvement processes, candidates with a background outside quality are also encouraged to apply.
In collaboration with stakeholders you’ll be supporting our construction, engineering and automation activities on review and approval of validation strategies, engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where QA needs to approve before implementation and upon completion. You’ll also be an active member of cross functional groups where quality input is needed.

Primary Responsibilities

• Execute QE activities during change overs from one product to another
• Review/approval validation documentation and additional test of protocols and reports
• Review/approval of change control/Deviations documents and activities associated with change control implementation
• Support Automation / IT function on smaller and larger projects.
• Reviewing documentation for compliance to internal procedures and applicable regulatory and corporate guidance documents.
• Identify and implement improvements of operations both in own function and cross functionally

Qualifications

We are looking for a high performing and driven individual who values strong teamwork at all levels and perform their work with an open mind and a sense of humor. Furthermore, we are looking for the following:


• Knowledge of production methodology involved in biopharmaceutical production
• Experience with qualification/validation of IT systems and/or production equipment
• Good communication skills and fluency in English

Education

• B.Sc. or M.Sc. in physical, chemical or biological science, Technical Engineer or equivalent


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