Sr. QA Officer
About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) 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 and biologics. Pharming is headquartered in Leiden, the 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.
Purpose of the role
As a Senior QA Officer at Pharming, your primary responsibility is to ensure the compliance of the quality systems at Pharming, external partners, and contractors with EU and USA GMP legislation, guidelines, and Pharming's quality expectations. In this crucial role, you will provide expert advice to employees and managers on QA-related matters. You advise employees and managers on QA related matters and evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP.
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 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, CAPA’s, Risk Assessments, protocols and reports.
- 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. Initiates, formulates and implements new processes and procedures within area of expertise.
- Communicate and negotiate with contractors and suppliers, with respect to deviations, audits and complex projects.
- Proactively propose ideas for site improvements; and provide subject matter expert reports as required.
- Performing and reviewing internal and external audits, as lead auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP).
- Represents QA dept in significant complex projects.
Knowledge:
- BSc Biotechnology, chemistry, biopharmaceutics or equivalent
Experience:
- Six years of experience in (bio)pharmaceutical environment with at least four years 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.