QA Specialist

Are you an enthusiastic QA Specialist Do you enjoy working in a scale-up environment Do you have GMP experience Are you based in the Leiden area Then keep reading!

Who are we

NecstGen is a leading CDMO (Contract Development and Manufacturing Organization) focused on process development and GMP manufacturing of cell and gene therapies. We are an independent non-profit organization with a state-of-the-art facility in Leiden specifically designed to develop manufacture and deliver these complex therapies to patients.

NecstGen is an independent subsidiary of the Leiden University Medical Center (LUMC). Thanks to this independent position we can fully focus on innovation and accessibility in cell and gene therapy. Our location at the Leiden Bio Science Park one of Europes largest life sciences clusters offers direct access to a network of experts partners and emerging talent.

By investing in advanced manufacturing technologies and strategic collaborations we support academic institutions start-ups and biopharmaceutical companies in scaling up their innovative therapies. Our expertise and flexible approach enable organizations to execute complex manufacturing processes efficiently and according to the highest quality standards.

Working at NecstGen means:

• Contributing to the future of healthcare with innovative cell and gene therapies.

• Working in a modern high-tech environment with the latest equipment.

• Being part of a close-knit and motivated team where collaboration and growth are central.

• The opportunity for professional development in a fast-growing sector with many career advancement opportunities.

• Working at a strategic location in the Leiden Bio Science Park at the heart of an international network of experts and companies.

What will you do

As a QA Specialist you will:

• Support effective implementation monitoring reporting maintenance and administration of the quality management system;

• Support monitoring and reporting of compliance of the organization and its activities with GMP and other relevant legislation and regulations;

• Act as trainer coach and expert on QA related matters and systems for other NecstGen colleagues;

• Ensure effective and timely handling of quality issues (deviations complaints) and monitor the application and efficiency of corrective and preventive actions;

• Support creation of SOPs policies and other QA related documentation (writing review approval) in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized;

• Support (review and approval) of Risk Assessments qualification/validation protocols and reports of analytical methods equipment and facility QC testing documentation specifications materials and release documentation batch records etc to ensure compliance with applicable guidelines and procedures;

• Assist compilation of documentation for QP disposition;

• Represent QA department in projects;

• Propagate continuous improvement by identifying and communicating areas for improvement. Initiate formulate and implement new processes and procedures within area of expertise;

• Participate in the Supplier Qualification process;

• Support the organization hosting and reporting of inspections and audits and coordination of related CAPAs;

• Conduct internal audits and inspections at suppliers and third parties to whom GMP activities are outsourced; qualification and monitoring of those suppliers and third parties.
  
  

Who are you

• MSc in Biotechnology chemistry biopharmaceutics or equivalent;

• Proficiency in cGMPs GDPs and regulations promulgated by the EMA or equivalent regulatory Agencies;

• Three years of recent experience in (bio)pharmaceutical environment with at least one years of recent experience in Quality Assurance;

• Experience within a sterile manufacturing environment preferable ATMPs (biologicals vaccines injectables parenteral);

• Good communication skills in English (in writing and verbally);

• Willingness to travel: occasional travelling may be required to support the auditing program.

What do we offer you

• A monthly salary between 3413 and 5409 (based on a 36-hour workweek);

• A 13th-month bonus paid in November;

• 26 vacation days for a full-time (36-hour) position;

• A premium-free pension scheme;

• Travel allowance for commuting (from 10 km) of 0.23 per km and full reimbursement of public transport costs;

• Various flexible employment benefits in addition to the above.

Questions
Dont hesitate to contact Diederik Pardon atfor more information.