Quality Qualified Person

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

We are looking for an experienced Qualified Person (QP) to join a leading pharmaceutical organisation. This role will be responsible for ensuring products are released in compliance with GMP requirements and applicable regulatory standards, while supporting quality improvements across manufacturing operations.

Key responsibilities include:

• Reviewing and approving batch documentation, specifications, and quality records.
• Making release or rejection decisions based on quality investigations and product compliance.
• Managing deviations, investigations, CAPAs, and quality improvement activities.
• Approving Product Quality Reviews and ongoing stability studies.
• Supporting regulatory and customer inspections, including audit preparation and follow-up activities.
• Coordinating product complaint investigations, recalls, and root cause analyses.
• Working closely with manufacturing, quality, and technical teams to ensure compliance and continuous improvement.
• Providing guidance and leadership to QA team members and supporting training and development initiatives.
• Participating in technology transfer projects and maintaining strong relationships with internal and external stakeholders.

Requirements

• Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Eligibility to act as a Qualified Person in accordance with EU regulations.
• Strong experience within aseptic pharmaceutical manufacturing environments.
• Experience with sterile processing; lyophilisation and visual inspection experience is advantageous.
• Good understanding of EU and US GMP regulations.
• Knowledge of automated manufacturing processes and analytical testing methods.
• Proven experience managing quality investigations, deviations, complaints, and product release activities.

What We're Looking For

• Strong decision-making and problem-solving skills.
• Ability to influence and collaborate with cross-functional teams.
• Results-driven with a focus on quality and compliance.
• Excellent communication and stakeholder management skills.
• Organised, proactive, and able to perform in a fast-paced regulated environment.