Quality Assurance Associate (IT)

Quality Assurance Associate I

On behalf of our client a leading Pharmaceutical company in Zug, we are looking for a Quality Assurance Associate for a 12 month contract.

SUMMARY:

• Responsible for batch record review and disposition pack preparation for all manufacturing steps with focus on Finished Good Products (75%), as well as Drug Product and DS/APIs manufactured at CMOs (Parenteral and Pharmaceuticals) where required.
• Coordinate with Quality colleagues and cross-functional departments (i.e. External Manufacturing, Logistics and Planning) on batch status, Certificate of Analysis status, Annual Product Review, CMO assessments, Deviations, changes and CAPAs related to the batch documentation and approved as needed.

REQUIREMENTS:

• A minimum of 1- 2years of experience in similar position in pharmaceutical or biotechnology industries.
• Requires a good understanding of review and release process, and a general understanding of the manufacturing and QC steps of pharmaceutical and parenteral products, including validation activities.
• Sound knowledge of cGMP requirements, EU/FDA regulations and compliance.
• Experience in clinical products manufacturing and/or regulatory is an asset.
• Knowledge of Trackwise and Oracle EBS are desirable.
• Knowledge of medical device regulations and manufacturing is a plus.

If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Elaine Kanwar on +41 61 282 22 23

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