Senior Quality Assurance 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 has its headquarters in Leiden and is growing quickly. As a result of this growth, we are looking for a Senior Quality Assurance Officer in Leiden.
About the role:
The Senior 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. The Senior QA Officer advises employees and managers on QA related matters. He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP.
Areas of responsibilities:
- 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, coach 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.
Required skills & qualifications in order to be successful in this role:
- Quality oriented
- Problem analysis
- Problem solving
- Behavioral flexibility
- Education: BSc. Biotechnology, chemistry, biopharmaceutics or equivalent
- Technical skills: Extensive knowledge of and experience with GMP regulations for EU and US. (like GMP, GLP, ISO, GDP, GCP)
- Six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance.