Quality Assurance Specialist

• Feb 2022 - Present

working on various QA tasks including but not limited to:1. Preparation, Review and approval of various documents like SOPs, deviations, change control, master manufacturing and packaging batch records, CAPAs, specifications, validation and qualification protocols and reports.2. QA review and approval of batch records prior to QP review and release. 3. Participation in authority inspections, customer audits and internal inspections. 4. Leading internal and customer audit CAPA plans. 5. Regulatory and Pharmacovigilance tasks.6. Supplier Qualification Show less

Quality Assurance Chemist

• Oct 2020 - Present

GMP Intern

• Feb 2020 - Jul 2020

My internship at Bavarian Nordic (BN) was mainly in the production support department at the Improvement and Compliance team I&C, and I also had some training and tasks at the QA department. During my internship I attended plenty of GMP related meetings across departments such as: department white board meetings, KPI meetings, audit observations, release meetings, and technology transfer meetings. Moreover, I had the chance to attend training in Bavarian Nordic production upstream processes and observe them at their production site in Kvistgård. Tasks I performed/helped at at Bavarian Nordic include: 1. Daily participation in team’s white board meetings either on site or online (during Corona pandemic) to assign the goals of the day and discuss the progress of pending tasks. 2. Followed the work performed on change requests and deviations from their initiation until closure by QA. I also had the chance to work on 2 deviations, and lead both the writing as well as organizing meetings across departments, to collect the information needed to find the root cause. 3. Joined the process of Systematic Problem Solving (A3) training module build up, and followed the training itself which I applied on two deviations I was working on, where tools like ‘5 times why’ and fishbone were used to find the root cause 4. Joined several improvement meetings at the team, and learned more about LEAN and the various tools used, such as value stream mapping and Kaizen. 5. Updating standard operating procedures (SOP). 6. QA tasks: updating ISO standards used at BN, reviewing batch journals and collection of data and transform a Quality oversight report to a form which is much more convenient for QA. 7. At the QA department, I joined QA specialists and QPs during reviewing batch journals, extending expiry date of BN products and approval of raw materials or products for release. Show less

GMP

• Jan 2020 - Mar 2020

Goals of the course: 1. Assuring an in-depth knowledge of current legislation for the manufacture and distribution of medicines. 2. Understanding of evaluating the individual steps in the implementation of the rules and the quality system 3. Documentation (traceability, batch documentation, archiving) deviations, change requests, CAPA, reclamation. SOPsThe following pensum was followed during the course: EudraLex vol. 4, Introduction EudraLex vol. 4, Part I EudraLex vol. 4, Annex 1, 8, 9, 15 og 19 EudraLex vol. 4, Glossary GMP-bekendtgørelse 1358 af 18. december 2012 GDP-bekendtgørelse 1694 af 18. december 2018 Lægemiddellov 99 af 16. januar 2018 EudraLex vol. 4, Part II EudraLex vol. 4, Part III (SMF, Q9 (QRM) og Q10 (Pharmaceutical quality sytstem)) GDP-vejledning 5. november 2013 Show less

Maternity Leave

• Jul 2018 - Aug 2019

Regulatory Surveillance Translator

• Dec 2016 - Jun 2017

My tasks at Tarius were the following: 1. Updating the pharmaceutical document content of the databases by monitoring relevant websites in Arabic. 2. Classification and registration of pharmaceutical documents. 3. Writing short descriptive abstracts of pharmaceutical documents in English. 4. Validation of existing document content. My tasks at Tarius were the following: 1. Updating the pharmaceutical document content of the databases by monitoring relevant websites in Arabic. 2. Classification and registration of pharmaceutical documents. 3. Writing short descriptive abstracts of pharmaceutical documents in English. 4. Validation of existing document content.

Trainee

• Sep 2013 - Jan 2014

Trainee

• Jun 2013 - Aug 2013