Quality Unit Manager and Qualified Person
1 mese fa
Antal International Network is a leading multinational headhunting company with a strong presence in 40 countries. Our Life Science team specializes in recruiting professionals with a scientific and engineering background in various industries, including pharmaceuticals, biotechnology, and medical devices.
We are currently seeking a Quality Unit Manager and Qualified Person to join our team. As a key member of our quality team, you will be responsible for ensuring the compliance of our products with regulatory requirements and industry standards.
Key Responsibilities:
- Manage the batch disposition process to ensure timely release of products.
- Ensure the batch disposition process maintains compliance with site practices and regulatory requirements.
- Support major investigations, ensuring all product deviations are closed prior to batch release.
- Participate in cross-functional teams as Quality/Qualified Person representative.
- Provide additional QP support to quality-related issues, as needed.
- Participate on internal committees/teams, as required.
- Provide advice and direction to other departments on quality issues.
- Reporting to Quality Unit site Director, ensure independence of the QP on 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 program and supplier audits.
Requirements:
- Postgraduate qualification required (MSc or equivalent).
- 8+ years of cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorization (MIA).
- Experience in managing Health Authority audits, CAPA plan, and its related documentation.
- Pharmaceutical manufacturing experience in Sterile and API manufacturing highly desirable.
- Proven leadership skills comparable to 2+ years of management responsibility.
- Problem-solving, risk assessment, and impact analysis abilities.
- Training/mentoring experience.
- Italian and English fluent languages.
If you are a motivated and experienced professional looking for a new challenge, please submit your CV and motivation letter to us. We look forward to hearing from you.
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