Pharmacist with scientific background

1/2018 – 10/2019

Whilst employed by Aston Life Sciences I worked as an external employee at Novartis. My responsibilities at Novartis were:
• To design, plan, perform, interpret and report results of scientific formulation experiments for the preparation and timely delivery of solid oral drug products (late phase) including GMP manufacturing.
• To lead and manage all formulation activities performed at Contract Manufacturing Organisations, support and coach team members, participate in scientific teams and contribute to the overall Technical Research and Development strategies and goals.
• To investigate deviations (internal and external) using various tools and perform impact and risk assessments as well as carry out related actions, e.g. assigned CAPA tasks plus effectiveness checks.
At Novartis I was a part of a team developing a paediatric formulation. During this project I gained knowledge on various HA requirements regarding paediatrics. This includes excipient levels (e.g. colourants and sweeteners) and dosage forms (e.g. tablet size and chewable tablet hardness limits). I also participated in an evaluation of a novel API pellet manufacturing method and its' suitability for a paediatric PiB.

Part of my role as an FPL was to work with 3rd parties. I reviewed batch manufacturing records prior to and after manufacturing. My attention to detail and thoroughness impressed my colleagues in the QA department. I also dealt with the logistics of sending raw materials, and investigated deviations (incorrect process parameters, expired raw material, data integrity). Especially during 3rd party deviation handling I had to use my influencing and communication skills and perseverance to get the information and data that I needed to make conclusions of product quality and overall compliance to the GMP.

During my time at Novartis I helped my colleagues with their work by e.g. performing data integrity checks as well as batch record reviews despite my own busy schedule. I also got recognised for a job well done in my own project when taking the lead in a 3rd party deviation.

Pharmazie