QA/QE Specialist for Finished Goods Manufacturing and Drug Substance MFG

Are you a self-driven and motivated team-player with a “go-do” attitude, and are you a person who takes ownership and responsibility of your assignments? Then you might be our new colleague!
We are currently looking for an experienced person with a technical background and experience from working in a GMP environment to join our Quality Assurance Engineering team in Hillerød.

This team is part of the Quality Assurance Operations department for Finished Goods Manufacturing (FGM) and Drug Substance Manufacturing (DSM). Since 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, Quality Control 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.
•    Review documentation for compliance to internal procedures and applicable regulatory and corporate guidance documents.
•    Identify and implement improvements of operations both in your 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 humour. Furthermore, we are looking for the following:

•    +5 years of experience with bio-pharmaceutical production of FGM and/or DSM are required.
•    Knowledge of bio-pharmaceutical production within Fill Finish, Utility, Pen’s/devices and Automation/IT are an advantage.
•    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.

Please upload your CV and cover letter latest by December 12th.

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