CQA officer
About Pharming
Pharming Group N.V. (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.
Our Culture
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.
About the team:
The QA team is a fresh, dynamic team. All experience and expertise from each employee is applied in the best possible way. By working as a team, open communication lines and a willingness to help and train each other, we reach our team goals. As a result of the continuous growth, we are looking for an enthusiastic QA Officer.
Purpose of the rol
The QA officer ensures that the quality system at Pharming, external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP.
He or she ensure that the systems for Pharmacovigilence are compliant with GVP guidelines.
Areas of responsibility:
- 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 and ensure this is organized.
- Act as co-trainer and expert for other Quality Assurance Officers.
- Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, and CAPA’s.
- Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Identify and communicate areas for improvement.
- Propose ideas for site improvements.
- Preparing and supporting internal and external audits in relation to applicable guidelines (like GVP, GMP, GLP, ISO, GDP, GCP).
Your profile
Knowledge:
- BSc. Biotechnology, chemistry, biopharmaceutics or equivalent
- Knowledge of and experience with GMP regulations for EU and USA. (like GMP, GLP, ISO, GDP, GCP)
Experience:
- Four years of experience in (bio)pharmaceutical environment with at least one year in Quality Assurance.
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
You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.
Also important! We truly value a healthy life-work balance with a lot of flexibility.
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!
We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.