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Associate, Quality Assurance

We have an exciting new opportunity for Quality Professional to join our QA Downstream team based at our manufacturing facility in Hillerød, Denmark.

Job Category

Quality

Requisition Number

33623BR

Job Description

In this role, you will assess the drug substance quality through review of solution records and batch production record and through being on the floor during manufacturing as applicable.

You will maintain the quality system related to the exceptions and disposition processes based on current GMP, GDP and regulatory requirements. 

Primary Responsibilities
- Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records utilized during batch manufacturing
- Act as primary QA contact for the LSM Compliance team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance. Including participation in on-line trouble shooting and investigations as needed. Perform QA Assessment and Approval of Global Changes (GCC
- Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition
- Participate in execution of audits and inspections from competent authorities and external parties and act as subject matter expert

Qualifications

- Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry
- Knowledge of GMP and quality system
- Work experience from pharmaceutical industry, in QA preferably
- Work experience or educational background that allows for understanding of the complexity of manufacturing biologics

Education

- Preferably Master of Science, e.g. Pharmacy, Biotechnology, Biology or similar

Employment Category

Full-Time Regular

Experience Level

Entry Level


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