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JOB DESCRIPTION:

We are seeking a highly motivated individual to join our QA Advanced Therapies team, located in Sassenheim, the Netherlands. QA-AT supports the clinical and commercial manufacturing of Lentivirus, an important component for Johnson and Johnson’s CAR-T therapy.
The Specialist QA acts as a quality expert and ensures quality oversight of our AT products and processes. Plays a crucial role in ensuring that our manufacturing operations meet the highest standards of quality and GMP compliance by supporting various base business activities needing quality assurance expertise. The Specialist QA works in close collaboration with other local or global departments (Operations, Warehouse, QC, GET, MSAT and other site Quality teams).

EXPERIENCE AND SKILLS

• Degree in science related subject and /or business-related area with 2-4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. QA experience preferred.
• Knowledge of current Quality Management principles, GMP and Quality Systems, Pharma regulations.
• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.
• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.
• Problem solving, analytical thinking and decision making capabilities.
• Demonstrated proficiency in English both in word and in writing. Dutch is a pre but not mandatory.

• Reviews and approves routine GMP documentation for all components of the Quality system.
• Reviews and approves validation protocols and reports, CSV documentation, change controls, validation assessments, URS and applicable lifecycle documentation.
• Reviews and approves release documentation for (raw) materials or Drug Substance , including QA review of electronic batch records and related documentation (e.g., QC test results, QC trending data, SAP tags and related change controls).
• Reviews and approves Maintenance notifications and work orders (NI-NS) and SAP-PM Master Data Changes (N2, N5 and N6), as well as the approval of Maintenance and Calibration related documents (as needed).
• Executes Quality Aseptic Processing Oversight activities, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.
• Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.
• Performs the Quality review of Periodic Review reports.
• Quality overview of the validated state of the utilities, equipment and processes.
• Promotes improvement initiatives to set up , standardize and lean out QA processes within the team.
• Provides Site support for local or global projects as an SME or QA core team member.
• Engages in internal audits and inspections as an SME or in support functions.
• Escalates serious quality, compliance and /or GMP incidents to management.
• On a rotation basis is available for beeper duty on out office hours and if quality oversight is needed during manufacturing (e.g. QAPOP)