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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.

Qualifications  

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


Education  

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

For further details, Please contact Click Here

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