QA Associate - Zug, Schweiz - Hobson Prior
Beschreibung
Salary:
CHF60 - CHF70 per hour
Job type:
Interim/Contract
Location:
Zug, Switzerland
Function:
Quality Assurance, Quality Systems
Posted:08/12/2021
Ref:
BBBH17750
- Hi I'm
, I manage this role
Hobson Prior are seeking a QA Associate to join a biotechnology company whose mission is to improve the lives of people with cancer through innovative targeted therapies.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- Manage lot review activities for clinical and commercial GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are met.
- Review and mange deviations from contractors related to manufacturing and testing.
- Review executed batch production records to ensure compliance with approved procedures quality agreements and GMP expectations.
- Communicate and resolve discrepancies with CMOs.
- Compile and manage lot files.
- Enter data in to process monitoring system draft PQR sections.
- Participate in quality system improvements.
- Revise standard operating procedures and associated work instructions. Authoring SOPs is also possible under supervision.
- Monitoring local and global team meetings and project progress to ensure efficient and effective communication on project status and issues.
Requirements:
- BS/BA or Master's Degree in a relevant field.
- 3+ years' experience in the regulated pharmaceutical industry, with 12 years in QA or manufacturing.
- Knowledge and experience with US/EU GMPs, ICH and other applicable international regulations.
- Experience with the production and testing of pharmaceuticals (biologic or small molecules).
- Experience working with contract givers preferred.
- Excellent communication skills and proven ability to work well with internal and external teams.
- Experience with electronic documentation management systems preferred.
- Ability to prioritise work and handle multiple assignments, while maintaining a high level of quality.
- Fluency in English is a must.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
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