i-Pharm Consulting
Qualified Person (QP)
posted 1 day ago
Location
Haarlem, North Holland, Netherlands
Employment type
Freelance or Agency
Workplace
On-Site
Experience
Expert
Commitment
Full-time
We are seeking an experienced Qualified Person (QP) to join a prominent pharmaceutical organization for a 3-month onsite contract. In this role, you will be responsible for ensuring that products are released in accordance with GMP requirements and relevant regulatory standards, while also supporting quality enhancements across manufacturing operations.
Vacancy Summary
Join a leading pharmaceutical organization as a Qualified Person (QP) on a 3-month onsite contract. Ensure compliance with GMP regulations and drive quality improvements in manufacturing operations.
The Role
You will be tasked with reviewing and approving batch documentation, specifications, and quality records. You will make release or rejection decisions based on quality investigations and product compliance, manage deviations, investigations, CAPAs, and quality improvement activities. Additionally, you will approve Product Quality Reviews and ongoing stability studies, support regulatory and customer inspections, including audit preparation and follow-up activities, and coordinate product complaint investigations, recalls, and root cause analyses. Collaboration with manufacturing, quality, and technical teams is essential to ensure compliance and continuous improvement. You will also provide guidance and leadership to QA team members and support training and development initiatives, while 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.
Required skills
Communication
Analyses
CAPA
Good Manufacturing Practices (GMP)
Cross-functional Collaboration
Automated Manufacturing
Chemistry
Investigations
Testing Methods
Quality Improvement
About i-Pharm Consulting
i-Pharm Consulting
Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. We have specialist teams working from offices in London, New York and Sydney, focusing on the US, Europe and APAC regions. Driven by our mission of “changing lives by placing people at the heart of life sciences’, we provide tailor-made solutions to our global client base. We have specialised solely in life sciences from the start. By focusing on selected functional markets, we have built a deep understanding of the needs, opportunities, challenges and cultural nuances in each of our areas of specialism. Coupled with a thorough understanding of each client, and a global network of candidates nurtured over our thirteen years, this puts us in a unique position: we provide unrivalled insight, advice and support to ensure the right technical and cultural alignment, every time. We an source talent across a range of services, offering our clients flexible solutions to successfully deliver projects on time and on budget. - Permanent Recruitment - Contract Recruitment - Executive Search Operating in a complex and fast-changing industry sector, we understand the importance of specialist knowledge. We work across the Pharmaceutical, Biotech and MedTech sectors, with a particular focus on the following specialist areas. Drug Development - Clinical - AI, Data Science & Biometrics - Quality Assurance & Tech Ops - Regulatory Affairs - Commercial - Medical & Scientific MedTech - Commercial - Quality Assurance / Regulatory Affairs - Research & Development Life sciences has never played a more important role for society, and we’re determined to deliver even greater support in the years ahead.
Locations
London, GB
Website
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