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Quality Assurance Specialist - Hillerød - Denmark

Quality Assurance Specialist - Hillerød - Denmark

Jun 19,2017

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)

• Support quality KPIs by collecting and analysis of data.


 Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry. Process knowledge on biotech processes would be an advantage.


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

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