Quality Assurance Manager
7 giorni fa
Job Summary
The Antal International Network is seeking a highly experienced Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our sterile manufacturing processes.
Key Responsibilities
- Manage the batch disposition process to ensure timely release of products, ensuring compliance with regulatory requirements and company practices.
- Support major investigations, ensuring all product deviations are closed prior to batch release, and participate in cross-functional teams as the Quality/Qualified Person representative.
- Provide additional QP support to quality-related issues, as needed, and participate on internal committees/teams, as required.
- Offer advice and direction to other departments on quality issues, reporting to the Quality Unit site Director, ensuring independence of the QP in decisions on quality-related matters.
- Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance, and continuous improvements.
- Provide audit support as required for internal auditing programs and supplier audits.
Requirements
- Pharmaceutical manufacturing experience in Sterile manufacturing, with a Post Graduate Qualification (MSc or equivalent).
- At least 8+ years of cGMP experience with relevant work experience acting as a Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA).
- Experience in managing Health Authority audits, CAPA plans, and related documentation.
- Proven leadership skills comparable to 2+ years of management responsibility.
- Problem-solving, risk assessment, and impact analysis abilities.
- Training/mentoring experience.
- Fluency in Italian and English.
What We Offer
The Antal International Network offers a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced Quality Assurance professional, we encourage you to apply for this exciting opportunity.
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