QP consultant

Randstad Belgium; Geel; On-site; EUR 120,000 - 150,000; Full time

Job summary

Randstad Belgium seeks a Qualified Person (QP) for a direct replacement role in a defined manufacturing area. You will serve as the primary QP contact for operational issues, guiding QA engineers and escalating deviations as needed.

You will review and approve batch release dossiers and CoAs, execute releases of commercial and clinical lots in the ERP system, and approve regulatory submissions and product specifications.

Qualifications

• Master of Industrial Pharmacy required.
• 8–10 years pharma experience preferred.
• Dutch and English fluency (spoken and written).

Responsibilities

• Serve as primary QP contact for operational issues in a defined manufacturing area.
• Provide QP guidance to QA engineers during early involvement meetings and identify deviations or changes for escalation to QP Governance.

Skills

Primary QP contact

Batch release

CoA review

QA guidance

Regulatory submissions

ERP system

Education

Master of Industrial Pharmacy

Tools

ERP system

Job description

• Serve as the primary QP contact point for operational issues in a defined manufacturing area.
• Provide QP-related guidance to QA engineers during early involvement meetings and identify deviations or changes requiring escalation to the QP Governance meeting.
• Perform detailed review and approval of batch release dossiers and Certificates of Analysis (CoA).
• Execute release of commercial and clinical lots in the ERP system for shipment to Drug Product sites.
• Review and approve deviations requiring QP involvement, as well as new submissions or major updates to regulatory filings.
• Approve Product Specification Sheets, export certificates for US-bound product samples, and shipments to Sanofi or partner sites outside existing agreements.
• Oversee and approve the exceptional use or destruction of site reference/reserve samples, and authorize requests to supply reserve samples to health authorities.

Out of Scope: Legal certification of batches in the release register (vrijgaveregister).

Candidate Profile:

• Education: Master of Industrial Pharmacy.
• Legal Status: Mandatory registration number on the official list of Qualified Persons (Articles 84 and 211 of the Royal Decree of 14 December 2006).
• Experience: Minimum 8–10 years in the pharmaceutical industry, ideally with prior experience acting as a QP, combined with comprehensive expertise in biotechnology production processes.
• Languages: Professional fluency in Dutch and English (spoken and written).

Hiring Context: Direct replacement role (skills-based hiring not enabled).