Hybrid RP & QP – GDP/GMP Compliance Lead

Cencora, Inc.; Veghel; Hybride; EUR 110 000 - 180 000; Plein temps

Avantages offerts par ce poste

Benefits vary by country

Résumé du poste

Alliance Healthcare Management Services Limited is recruiting for a hybrid role in the Netherlands combining GDP-focused Responsible Person duties (~80%) with GMP-focused Qualified Person responsibilities (~20%). You will ensure GDP compliance, oversee QMS, and coordinate with IGJ inspections and Dutch Opium Act considerations.

The QP duties include EU Directive 2001/83/EC compliance, batch release oversight, and supplier/contractor GMP assessment in collaboration with the RP.

Qualifications

• Demonstrated experience with GDP and GMP.
• Familiarity with IGJ inspections and Dutch regulatory framework.
• Experience in regulatory inspections and audits.
• Ability to act as RP under GDP and QP under EU directive.

Responsabilités

• Act as the Responsible Person (RP) under GDP and oversee GDP compliance.
• Act as Qualified Person (QP) for EU GMP release and batch documentation.
• Ensure GMP/QMS alignment and oversight of packaging, importation, and related activities.
• Lead GMP inspections and audits, and support regulatory authorities (IGJ).
• Review deviations, CAPAs, and product quality reviews in collaboration with RP.

Connaissances

GDP experience

GMP experience

IGJ familiarity

Regulatory inspections

Pharmacy degree

Formation

University degree in Pharmacy

Description du poste

Alliance Healthcare Management Services Limited is recruiting for a hybrid role in the Netherlands combining GDP-focused Responsible Person duties (~80%) with GMP-focused Qualified Person responsibilities (~20%). You will ensure GDP compliance, oversee QMS, and coordinate with IGJ inspections and Dutch Opium Act considerations.

The QP duties include EU Directive 2001/83/EC compliance, batch release oversight, and supplier/contractor GMP assessment in collaboration with the RP.