Qualified Person

3 weken geleden

Leiden, Nederland Stirling Q&R Ltd Voltijd

**Title**:Qualified Person (QP)
**Location**: Near Leiden, Netherlands (2 days per week in office)

**Key Responsibilities**:

- Certify batches of medicinal products for market release or clinical trials, ensuring compliance with GMP, EU, and Dutch regulations.
- Collaborate with production, quality control, quality assurance, and supply chain teams to ensure compliance with EU-GMP and relevant directives.
- Supervise manufacturing/import operations to ensure adherence to EU-GMP and Dutch laws.
- Evaluate deviations and participate in investigations to ensure product quality and compliance.
- Approve quality agreements, validation reports, and other critical documents.
- Participate in risk assessments, audits, and inspections.
- Manage the disposition of rejected, returned, or recalled products.
- Ensure GMP aspects and QP roles are implemented in the Quality Management System.
- Represent the company to competent authorities and initiate product recalls if necessary.

**Requirements**:

- University degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry/technology, or biology.
- Minimum 2 years of practical experience in a GMP-approved pharmaceutical manufacturing facility.
- Accepted by the Dutch Health Authority (IGJ) and listed on the company's Manufacturing and Import Authorization (MIA).
- Minimum **C1-level proficiency in Dutch** and English.
- Experience as a certifying QP for solid oral dosage forms and Investigational Medicinal Products (IMPs).
- Experience in quality assurance for **sterile products.**:

- Strong knowledge of EU GMP regulations and guidelines.

**Working Conditions**:

- Office-based role with flexibility to work from home 3 days per week.
- Some travel within the EU and occasional global travel for audits.
- Reports to the Lead Qualified Person (NL).

**Job Types**: Full-time, Permanent

Pay: €80.000,00 - €100.000,00 per year

Ability to commute/relocate:

- Leiden: Reliably commute or planning to relocate before starting work (preferred)

**Experience**:

- Sterile product: 2 years (required)
- Qualified Person: 2 years (preferred)

**Language**:

- Dutch (required)

Work authorization:

- Netherlands (required)

Work Location: In person

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