Senior QA Specialist (GMP Environment)

For our Quality Assurance team we are looking for a Senior QA Specialist. In this role you ensure that the GMP activities and Pharmaceutical Quality system of NecstGen are compliant with the applicable legislation, guidelines and/or NecstGen’s quality expectations, while pursuing continuous improvement. The Senior QA Specialist advises employees, contractors and clients on QA related matters.

What you will do

As a Senior 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 products 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;
• Act as back-up during Head of Quality absence.

What we ask
To be successful you have:

• MSc in Biotechnology, chemistry, biopharmaceutics or equivalent;
• Proficiency in cGMPs, GDPs and regulations promulgated by the EMA or equivalent regulatory Agencies;
• Eight years of recent experience in (bio)pharmaceutical environment with at least five 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 will be required to support the auditing program.

Offer
We think it is important that you feel comfortable at work and enjoy coming to the office. We offer a modern and inspiring working environment with a collegial atmosphere, a flat organization with short lines and good employment conditions. You will join the team at an early stage, giving you the unique opportunity to co-define the company and contribute to the NecstGen’s establishment.

• A competitive salary
• 8% holiday allowance
• Permanent 13^th month
• 25 holidays with a fulltime employment of 36 hours per week
• Commuting allowance (from 10 km) of € 0,23 per km and public transport is fully reimbursed
• A non-contributory pension scheme
• Several flexible employment conditions on top of the above conditions
• Exciting dynamics of a scale-up environment

About NecstGen

Together with our clients and partners we challenge today’s possibilities and enable the unthinkable. NecstGen primarily works with early-stage research organisations, start-ups, and SMEs to develop efficient processes and perform GMP manufacturing for cell and gene therapies. We engage openly with organisations worldwide! NecstGen is a subsidiary corporation of the Leiden University Medical Center. Our unique company formation enables us to be a mission based CDMO and Centre of Excellence. NecstGen’s 4,000+m² facility comprises of 13 cleanrooms plus development and Quality Control laboratories for the generation of novel therapeutics. Our team of 40 consists of professionals from industry and academia with an entrepreneurial mindset and a drive to make a difference. We have a flat organisational structure with a participative management style.
Visit our LinkedIn company page to learn more about our team and the latest developments.

We would love to hear from you!

If this position gets you excited, we would love to hear from you! Don’t hesitate to contact Warda Cardozo, Head of HR, at dl-hr@necstgen.com for more information.

We do not wish to be approached as a potential customer or client.

Unfortunately, sponsorships for Non-EU citizens are not available.