Senior QA Officer at Pharming Group
Pharming Group N.V. develops innovative protein therapeutics for the treatment of genetic disorders. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is small (approx. 220 employees, based internationally) and growing quickly.
The Senior QA officer ensures that the quality system at Pharming and external partners and contractors is compliant with EU and USA GMP legislation, guidelines, and Pharming quality expectations.
You get energy from working together in a team with an environment that is constantly changing. You are change, service, quality and patient oriented. To work in a fast-changing environment, you are independent, show ownership and flexibility.
You advise managers on QA related matters and you train and coach other employees. You will give advice, develop new work processes, procedures, new methods and improve existing working methods. You will evaluate and analyze documents required for product development, clinical trials and commercial batch release.
Main duties and responsibilities:
- Write, implement, review and maintain SOPs, policies and other QA documentation. Identify documents which need to be created or updated and ensure this is organized.
- Act as trainer, coach and expert for other Quality Assurance Officers.
- Organize meetings with Pharming departments to ensure problem resolution and conducting investigations associated with deviations, complaints, non-conformances, Change Controls, CAPA, Risk Assessments, protocols and reports.
- Review and analyze documentation related to development, preclinical or clinical and ensure compliance with relevant guidelines. Identify and communicate areas for improvement.
- Review and analyze documentation related to Ruconest batch records, specifications, and related documents to ensure compliance with guidelines.
- Communicate and negotiate with Contract Manufacturing Organizations (CMO) with respect to deviations, audits, and complex projects.
- Proposes ideas for site improvements; and provide subject matter expert reports as required.
- Performing and review internal and external audits to determine compliance with GMP
- Education: BSc. Biotechnology, chemistry, biofarmaceutics or equivalent field
- Experience: Six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance
- Technical skills: Extensive knowledge of and experience with GMP and GCP regulations for EU and USA
- Quality oriented