Qualified Person, Viral Vector Services Europe

Job content

When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

LOCATION/DIVISION SPECIFIC INFORMATION

The QP will provide support to all appropriate and relevant activities within Thermo Fisher Scientific’s Viral Vector Services in Seneffe and Gossielies , Belgium, and is expected to provide significant to support clients and colleagues across but not limited to the EMEA region

How will you make an impact?

The role has three primary functions, batch disposition and associated certifications full quality oversight of manufacturing and Quality Control, and hosting/conducting internal and external audits including client and authority audits. In addition, this will encompass significant diversity in dosage forms such as Sterile, Biologics, Viral Vector etc.. The QP will be encouraged to collaborate closely and provide a consultative approach to all the areas of VVS-EU.

The QP community is significant and covers many different sites in the network. He/She is encouraged to interact with all functions and is as an active member of this QP community, entering into QP agreements, providing thought leadership, and developing technical capabilities. Attendance and speaking at external forums with a cascade of technical detail to the QP community. EMEA QPs engage with QP trainees and provide mentoring, development, training, and guidance to those looking to qualify.

This is a fast paced and dynamic environment which requires intermediate and final QP certification over large Global supply chains as well as small compassionate use supplies.

What will you do?

• To provide Final QP batch certification in compliance with regulatory requirements and if required, specific client technical agreements.
• To provide QP GMP declarations including on site audits if required, in support of importation activities.
• Ensure that all necessary steps of manufacturing and Quality Control have been completed under accepted pharmaceutical quality systems to assure compliance of the batch with GMP, the MA and any other legal obligations in the Member State where certification is taking place.
• Participate in Quality Management Reviews and Supply Chain Management Reviews /S&OP meetings as applicable.
• Ensure that suppliers are approved in coordination with responsible departments. Approve any subcontracted activities, which may have impact on GMP.
• Support Product Complaints related investigation as necessary.
• Authorize recall in collaboration with Recall Committee.
• Negotiate QP to QP agreements, Quality technical agreements and other agreements in the oversight of the supply chains.
• Conducting internal and external audits as required. This might take the form of international assignments such as US, Asia and European destinations.
• To act as the Quality Lead, the primary contact point for Quality for major clients.
• Provision of thought leadership and actively providing new views on cutting edge regulatory/legislative and GxP training, completing blogs, internal and external speaking appointments as required.
• To provide information and training on the EU QP roles and responsibilities to Thermofisher Scientific personnel locally and Internationally.
• Provide support and mentoring to Trainee and newly qualified QPs.
• Support EMEA region in multisite critical initiatives to improve quality and compliance.
• Provide input/authoring on all aspects of the Global Quality management system, actively providing support and guidance on new policies and procedures as they are written and adopted.
• Support in larger scale investigations which could mean collaborating closely with sites across time zones and companies as well as in the extensive PSG network.
• Provide support to Business Development/ Sales and Project Management at pre-contract stage to assess new contracts.
• Reviews and approves PQR (product quality review)
• Maintain an up to date awareness of the regulatory issues affecting the clinical supplies process keeping relevant ThermoFisher colleagues informed where appropriate.
• To provide technical advice and support in the preparation of Technical Agreements.
• Lead/Support client audits/regulatory audits
• Potential for addition to multiple licenses in the region if desired/possible
• Developing expertise in EAP, Compassionate and named patient release globally.
• Consultation on appropriate Comparator sourcing strategies as applicable
• Advising on appropriate blinding processes and techniques as applicable
  

How will you get here?

EDUCATION

• Life Sciences Degree (Pharmacy)
  

Experience

• Experience in acting as a QP for Biologics/vaccines is an advantage
• Knowledge of pharmaceutical development process desirable
• Be willing to step through technical and leadership training and investment to complete a rigorous development process to focus on individual contribution as SME or Leadership progress.
• Actively willing to join external communities to drive and cascade key GxP and legislative changes into the business.
  

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

APPLY TODAY! HTTP://JOBS.THERMOFISHER.COM

Job Summary

Job number: 168390BR

Date posted : 2021-07-13

Profession: Quality & Regulatory

Employment type: Full-Time