Senior Qualified Person: IMPs & Branded Batch Release (EU)

SUN PHARMA; Hoofddorp; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

25 holidays + 1 extra day off on your

International environment

Job summary

SUN Pharma in the Netherlands seeks a Qualified Person to lead batch release and IMP certification for European and non‑European trials, ensuring compliance with Annex 13/16 and regulatory standards.

The role oversees QMS alignment, deviation/change control reviews, and supports inspections readiness while coordinating with global QA teams to uphold high pharmaceutical quality across commercial and clinical programs.

Qualifications

• Master’s Degree or equivalent in Chemistry, Pharmacy or relevant scientific field.
• Qualified Person certification or credential.

Responsibilities

• Be responsible for batch release and certification of IMPs and Pharma Branded products as primary Qualified Person; as stipulated in Annex 13 and 16 of Eudralex Vol 4.
• Review and prepare batch documents for QP Batch certification of clinical trial batches, and ensure proper maintenance of product specification files.
• Maintain compliance to European and local regulatory procedures for the management of clinical trials as per Good Clinical Practices (GCP).
• Support QMS: assist in implementing global standards and procedures, GAP assessments, and inspection readiness for external audits.
• Involvement in new projects and knowledge sharing of GxP requirements.

Skills

GxP Knowledge

EU GMP Knowledge

EU GDP Knowledge

Project Management

Communication Skills

Education

Master’s Degree in Chemistry, Pharmacy or relevant scientific field

Qualified Person

Job description

SUN Pharma in the Netherlands seeks a Qualified Person to lead batch release and IMP certification for European and non‑European trials, ensuring compliance with Annex 13/16 and regulatory standards.

The role oversees QMS alignment, deviation/change control reviews, and supports inspections readiness while coordinating with global QA teams to uphold high pharmaceutical quality across commercial and clinical programs.