Join a dynamic team at a leading Contract Manufacturing Organisation (CMO) and contribute to groundbreaking projects and cutting-edge solutions.
Proclinical is seeking a QA Project Manager for a contract role in Switzerland. This position focuses on supporting continuous improvement programs to enhance the Quality Management System within the cardiovascular therapy area. You will be a key player in cross-functional teams, ensuring effective execution of tasks related to Drug Product processes. This role is a maternity leave replacement.
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:
- Support continuous improvement initiatives for an effective Quality Management System.
- Represent Quality Assurance in cross-functional teams and maintain interfaces with Manufacturing, QC, and Support Functions.
- Assess, review, and approve quality records such as deviations, change control, CAPAs, and investigations.
- Author, review, and approve GMP-relevant documents and SOPs.
- Present Drug Product QA topics during customer audits and regulatory inspections.
- Participate in internal audits as required.
- Organize and manage monthly Quality Council & Risk Register meetings.
- Track and report key Quality indicators monthly.
- Conduct gap assessments for audit observations at other facilities.
- Act as a point of contact for Drug Product QA-related questions and issues.
- Support and approve project-specific risk assessments.
- Review and release product-specific documentation.
- Manage customer interactions regarding QA topics and handle changes, deviations, and technical complaints.
- Delegate responsibilities for Batch Disposition and conditional release.
Key Skills and Requirements:
- Strong understanding of Quality Management Systems and GMP regulations.
- Experience in managing quality records and conducting audits.
- Ability to work effectively in cross-functional teams.
- Excellent communication skills for customer interactions and presentations.
- Proficiency in tracking and reporting quality metrics.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
Apply Now:
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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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