Qualified Person - GMP Compliance & Product Release

i-Pharm Consulting; Haarlem; On-site; EUR 85,000 - 120,000; Full time

Job summary

i-Pharm Consulting is seeking an experienced Qualified Person (QP) to join a leading pharmaceutical organisation. The role ensures products are released in compliance with GMP and regulatory standards while supporting quality improvements across manufacturing operations.

Key responsibilities include reviewing batch documentation, making release decisions, managing deviations and CAPAs, approving Product Quality Reviews and audits, and supporting regulatory inspections.

Qualifications

• Eligible to act as a Qualified Person under EU regulations.
• Experience in aseptic pharmaceutical manufacturing.
• Sterile processing experience; lyophilisation and visual inspection advantageous.
• Strong knowledge of EU and US GMP regulations.
• Familiar with automated manufacturing processes and analytical testing methods.
• Proven experience managing quality investigations, deviations, complaints and product release activities.

Responsibilities

• Review and approve batch documentation, specifications and quality records.
• Make release or rejection decisions based on investigations and product compliance.
• Manage deviations, investigations, CAPAs, and quality improvements.
• Approve Product Quality Reviews and ongoing stability studies.
• Support regulatory and customer inspections, including audit preparation and follow-up activities.
• Coordinate product complaint investigations, recalls, and root cause analyses.
• Work closely with manufacturing, quality, and technical teams to ensure compliance and continuous improvement.
• Provide guidance and leadership to QA team members and support training and development initiatives.
• Participate in technology transfer projects and maintain strong relationships with internal and external stakeholders.

Skills

Decision-making

Problem-solving

Stakeholder management

Communication

Regulatory compliance

Education

Degree in Pharmacy, Chemistry or Biology

Job description

i-Pharm Consulting is seeking an experienced Qualified Person (QP) to join a leading pharmaceutical organisation. The role ensures products are released in compliance with GMP and regulatory standards while supporting quality improvements across manufacturing operations.

Key responsibilities include reviewing batch documentation, making release decisions, managing deviations and CAPAs, approving Product Quality Reviews and audits, and supporting regulatory inspections.