Quality System Specialist

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 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.
thway 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 Quality Systems Specialist.

About the role
The Quality Systems Specialist evaluates, analyzes and prepares the related documents for use, validation and qualification and advises employees and managers on QA related matters regarding computerized systems. He/she herewith ensures that all computerized systems (hardware or software) at Pharming with GxP impact are qualified and validated in compliance with current EU and USA GMP legislation. 
 

• Write, implement, review and maintain SOPs, policies and other QA related documentation in alignment with applicable GxP guidelines relevant for computerized systems. Identify documents which need to be created or updated and ensure this is organized.
• Act as trainer, coach and expert regarding computer system validation
• Set requirements for the configuration, validation, implementation and maintenance of automated quality systems and evaluate and approve the related documents
• In case QA is system owner by system owner configure, create validation, implementation and maintenance documents for the system.
• Act as Sys-Admin for automated systems within the QA department.
• Resolve problems and conduct investigations associated with configuration, validation, implementation deviations, Change Controls, Risk Assessments, protocols and reports in collaboration with BME and/or Pharming departments.
• Communicate and negotiate with contractors and suppliers, with respect to deviations, configuration, validation, implementation and complex projects.
• Proactively propose ideas for improvements; and provide subject matter expert reports as required.
• Performing and reviewing internal and external audits, as auditor, to determine compliance with applicable guidelines (like GMP, GLP, ISO, GDP, GCP) and specifically related to GxP computer systems.
• Participates and/or represents Quality Systems in significant complex projects related to GxP computer systems. 

What you'll need to succeed:​​​​​​

• Bachelors or University degree biopharmaceutical sciences, (bio)chemistry, engineering, ICT or equivalent
• Six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance. Including at least 3 years of experience with qualification and validation of computerized systems (hardware or software).
• Preferably experience with e-DMS (e.g. Master Control) and ERP (e.g. SAP)
• Extensive knowledge of and experience with GMP regulations for EU and US (GMP, GLP and GDP), specifically for computerized systems (e.g. such as EU-GMP Annex 11, US-CFR21 part 11 and GAMP-5)

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.