Senior Quality Assurance Specialist

About Batavia Biomanufacturing

Batavia Biomanufacturing significantly contributes to easing human suffering from infectious diseases, cancer, and rare diseases by leveraging our innovative technologies and in-depth know-how. We do this for viral vaccines and cell and gene therapies at all stages of the development trajectory, from the transition into early clinical studies to navigating late-stage clinical development and entering commercial manufacturing at higher speed, reduced costs, and with increased success. The company operates state-of-the-art development and manufacturing facilities in Europe and the US and, as part of the CJ CheilJedang global family, is building a strong position in global health with its strategic partners worldwide.

AREAS OF RESPONSIBILITY:

Quality Management System

• Translate GxP laws and regulations into established procedures. Ensure (new) company systems and processes are compliant with regulations and internal procedures
• Provide organizational support on the Quality Management System
• Handle and advise on complex Q-records and situations
• Advise in deviating situations on the basis of GxP laws and regulations
• Exemplary role in complying with internal procedures
• Discuss quality matters with other departments and provide binding advice
• Identify and, if necessary, escalate 'out of compliance' topics and have a leading role in resolving them.

Quality support

• Review and approve Quality Records and Quality Documents against internal procedures and GxP laws and regulations.
• Review processes and procedures against GxP laws and regulations.
• SME on the processes of deviation, CAPA, change control and documentation.
• Review and approve master documents for the manufacturing and testing.
• Review and approve stability plans and reports;
• Compliance with regulations, qualification and audit support
• Keep up to date with quality related regulations.
• Ensure all required suppliers are qualified. Conduct audits of various internal departments and external suppliers.
• Maintain and improve inspection readiness. Check whether processes are running in accordance with procedures and within the GxP regulations, identify deviations and draw up improvement proposals where necessary
• Monitoring the follow-up of points for improvement with internal and external parties
• Prepare and support audits by regulatory inspection bodies or customers (FO or BO)
• Training, development and coordination
• Provide training to employees within the organization in the field of quality and GxP
• Oversight of TMS, maintain and improve training structure for the company. Provide substantive input for the development of training courses
• Coaching of (junior) QA officers and employees in operational departments on quality related topics.
• Operational readiness and project support
• Review and approve qualification and validation documentation for facilities, utilities, equipment, assays and processes.
• Participate in or lead multidisciplinary project groups
• Advise on improvement measures on quality related topics

REQUIRED SKILLSETS/EXPERIENCE

• Bachelors or Master’s degree in relevant field, e.g., biosciences, pharmacy, process technology or engineering
• Relevant training on QA or GMP, solid understanding of pharmacopoeias, GMP and associated regulations.
• Experience: At least 5 years in (bio)pharmaceutical QA. Experience in writing/reviewing SOP’s, Deviations, CAPA and Change Controls
• Analytical, innovative and pragmatic thinking.
• Strong communication skills (oral and in writing, both Dutch and English)
• Additional skills:
• Experienced in working in a setting with short timelines, various products and transfers simultaneously (CDMO setting) is preferred.
• Affinity with biotechnology is preferred.
• Affinity with computerized systems is preferred.
• Experience as a QMS or DMS admin is a plus.