QA Specialist, Visp
vor 1 Tag
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Proclinical is seeking a QA Specialist to join our client's team in Visp, Switzerland. This role focuses on ensuring compliance with ISO/cGMP quality system requirements and providing immediate support to operations and quality control staff. You will be responsible for making independent quality-related decisions and supporting project teams with your regulatory and compliance expertise.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Verify compliance with ISO/cGMP quality system requirements.
- Provide on-the-floor QA support to operations and quality control staff.
- Make independent quality related decisions based on regulatory knowledge.
- Audit internal quality system elements in manufacturing and operational support areas.
- Oversee compliance of Change Controls, CA/PA, investigations, OOS, and deviations.
- Perform external audits of suppliers/vendors/offsite facilities.
- Act as a customer interface during audits and communications.
- Manage special projects or QA compliance functions as agreed with QA management.
- Review and approve validation documents and Master Batch Records.
- Perform review/release of batch records as needed.
Key Skills and Requirements:
- Experience in QA for commercial drug substances/products or aseptic processing and cell therapy manufacturing.
- Knowledge of GMP compliance and Part 11 compliance preferred.
- Familiarity with international aseptic processing regulations.
- Strong written and oral communication skills, with accurate documentation abilities.
- Ability to work in a fast paced, team oriented environment with independent work skills.
- Proficiency in Microsoft Office and database management.
- Strong organizational and recordkeeping skills, with the ability to handle multiple projects.
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