Quality Unit Manager and Qualified Person

TN Italy; Milano; In loco; EUR 50.000 - 90.000; Tempo pieno

Descrizione del lavoro

An established industry player in the pharmaceutical sector is seeking a Quality Unit Manager and Qualified Person to lead quality assurance efforts. This role involves managing batch dispositions, ensuring compliance with regulations, and supporting audits. The ideal candidate will have over eight years of cGMP experience, strong leadership skills, and a postgraduate qualification. Join a team committed to excellence and continuous improvement in a dynamic and supportive environment, where your contributions will directly impact product quality and safety.

Competenze

• 8+ years of cGMP experience as a Qualified Person.
• Experience in managing Health Authority audits and CAPA plans.
• Strong leadership and problem-solving skills.

Mansioni

• Manage batch disposition process for timely product release.
• Ensure compliance with regulatory requirements.
• Support internal and supplier audits.

Conoscenze

cGMP Experience

Quality Management

Problem-Solving Skills

Risk Assessment

Leadership Skills

Training and Mentoring

Fluency in Italian

Fluency in English

Formazione

Postgraduate Qualification (MSc or equivalent)

Descrizione del lavoro

Job Description

Antal International is a Multinational Headhunting Company with more than 140 offices in 40 countries. Our Life Science team specializes in profiles with a Scientific and Engineering background across Manufacturing, Production, Engineering, SCM, Research and Development, Medical, Quality, and Technical-Commercial sectors in Pharmaceuticals, Biotech, Chemicals, Cosmetics, Medical devices, Diagnostics, Plastics, Rubber, and Food industries.

The Company

A Multinational Pharmaceutical company is seeking a:

The Role

Quality Unit Manager and Qualified Person

The candidate will be responsible for:

1. Managing the batch disposition process to ensure the timely release of products.
2. Ensuring compliance of the batch disposition process with site practices and regulatory requirements.
3. Supporting major investigations and ensuring all product deviations are closed prior to batch release.
4. Participating in cross-functional teams as a Quality/Qualified Person representative.
5. Providing additional QP support for quality-related issues as needed.
6. Participating in internal committees and teams as required.
7. Providing advice and guidance to other departments on quality issues.
8. Reporting to the Quality Unit Site Director to maintain independence in quality decision-making.
9. Building partnerships across the business to foster a culture of excellence in quality, compliance, and continuous improvement.
10. Supporting internal and supplier audits as required.

Personal Attributes

1. Postgraduate qualification (MSc or equivalent).
2. Ideally 8+ years of cGMP experience, with relevant work as a Qualified Person, including being named on the Manufacturer's/Importer’s Authorization (MIA). Consideration will be given to other relevant experience and education.
3. Experience managing Health Authority audits, CAPA plans, and related documentation.
4. Experience in pharmaceutical manufacturing, especially in Sterile and API production, is highly desirable.
5. Proven leadership skills with at least 2 years of management responsibility.
6. Strong problem-solving, risk assessment, and impact analysis skills.
7. Experience in training and mentoring others.
8. Fluency in Italian and English.

Location: MILANO OVEST

Ref: Quality Unit Manager and Qualified Person

If not meeting all requirements, please indicate as 'SELF-CANDIDATION'. Applications will be reviewed and contacted within 30 days. We appreciate all CV submissions; if not contacted, your profile may be considered for future opportunities.

Check Your Resume for Match

Upload your resume to have it compared to this job's requirements, similar to how recruiters evaluate candidates.