Sr Associate I, Quality Assurance

Summary

Do you have solid GMP knowledge and some experience working in the pharmaceutical industry? Then we have a great new opportunity for you!

Job Category

Quality

Requisition Number

34235BR

Job Description

We are currently looking for a Quality Professional to join our QA LSM Operations team in Hillerød!

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

You will also 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 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
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications

Qualifications

- Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry
- 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

Associate


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