QA Officer
About Pharming Group N.V.
Pharming Group N.V. is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. We are developing and commercializing a portfolio of innovative medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, with a significant proportion of its employees based in the U.S.
Our Vision
Our Vision is to develop a leading global rare disease company with a diverse portfolio and presence in large markets, leveraging proven and efficient clinical development, supply chain, and commercial infrastructure.
Life at Pharming
Today more than ever, we're positioned to realize our vision of becoming a leading global rare disease company. Our success will come from everyone's commitment to our patients, our ability to work with focus and clarity, and our shared dedication to building something meaningful together. We can only achieve this by embracing our biotech culture, Life at Pharming, which is dynamic, experimental, and shaped by what we learn together.
The role:
We are looking for a QA Officer specializing in Quality Systems.
This role is pivotal in implementing, enhancing, and maintaining the quality systems within our organization. As a subject matter expert (SME), you will ensure these systems are utilized effectively and remain compliant with current EU and US pharmaceutical regulations.Your primary responsibilities include preparing, organizing, and archiving quality records and documentation in alignment with GxP requirements, industry guidelines, and Pharming’s quality standards. In addition, you will provide guidance, support, and customer service for inquiries related to the electronic Quality Management System (eQMS), ensuring smooth and efficient operations.
Areas of responsibility:
- Implement, improve and maintain parts of the Quality Management System.
- Provide SME input on the use of the quality documentation system, making sure it meets the requirements for compliance with current EU and USA pharmaceutical legislation (e.g. GMP, GDP, GCP, Data Privacy, etcetera).
- Key player in application, maintenance and projects related to the documentation quality system.
- Write, implement, review, and maintain SOPs, policies, and other QA related documentation in alignment with applicable GxP guidelines.
- Identify documents which need to be created or updated ensuring optimal GxP compliance.
- Manage the service desk and provide support to users of the quality documentation system.
- Collaborate with cross-functional teams to ensure the accuracy, completeness, and integrity of quality records in the applicable systems.
- Act as trainer and coach for the more junior colleagues regarding the use of quality systems.
Your profile:
Knowledge:
- Bachelors (bio)pharmaceutical sciences, (bio)chemistry or equivalent.
- Knowledge of GxP regulations (EU, US) and US-CFR21 part 11 where basic knowledge of relevant GxP regulations and quality systems is a must.
- Good knowledge and experience with ERP and eQMS.
- Affinity with computerized systems.
- Writing and speaking in Dutch and English.
- Preferably knowledge and experience of Project management.
Experience:
- Four years of experience in (bio)pharmaceutical environment where at least 1 year in Quality Assurance.
- Minimum 2 years of experience with Microsoft Office (word, excel etc.).
- Minimum 1 year of experience in a (bio)pharmaceutical environment with pharmaceutical document archiving systems.
- Experience with pharmaceutical eQMS systems (e.g., MasterControl) and/or SharePoint is a plus.
- Experience with GMP regulations for EU and USA (like GMP, GLP, ISO, GDP, GCP).
What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:
- A highly competitive salary
- 8.33% holiday allowance (for NL)
- A minimum of 30 vacation days
- An excellent pension plan
- Commuting allowance
Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you