Quality Assurance Officer

• Mar 2020 - Present

Quality Customer Controller

• Jan 2018 - Mar 2020

• Ensure compliance to ISO 13485 and GMP manufacturing• In-depth knowledge of the company’s processes and medical device platforms (self-injection pens)• Customer liaison for product quality• Initiating and assisting the closure of Deviations, CAPAs, and Change Controls• Conducting and assisting in Investigations and Root Cause Analyses, as well as participating in FMEA sessions as SME• Completing regular Product Quality Reviews for non-medicinal devices and trending exception data• Supporting customer visits and Business Review meetings• Aid process improvement projects• Support Customer and Notified Body audits, assist in the preparation of audit responses, track the resulting CAPA actions for timely completion • Ensure compliance to the customers’ Quality Technical Agreements and product specifications• Support complaint investigations

Global Access Medical Information Specialist

• Jan 2017 - Dec 2017

Providing medical information to internal and external customers in line with the ABPI code of practice. Liaison with suppliers and manufacturers for medical information responses and documentation. Ensuring all information in the product database is current and checking new and existing database entries regularly. Sourcing SPCs, PILs and other documentation. Keeping track of the TSE/BSE certification of products to ensure compliance with EU guidelines. Managing translation requests. Running monthly reports on the medical information database and reconciliation with clients.

Multilingual Medical Information Officer

• Apr 2015 - Dec 2016

Providing medical information in a timely manner to ensure patient safety and meet client-specific deadlines. Recognising Adverse Events and Product Quality Complaints and processing them accordingly. Liaising with clients for further information and being the first point of contact for some to manage escalations. Providing training on certain products, processes and the use of databases. Checking escalations, weekly reports and follow-up letters. Translating to and from Hungarian as necessary. Providing medical information in a timely manner to ensure patient safety and meet client-specific deadlines. Recognising Adverse Events and Product Quality Complaints and processing them accordingly. Liaising with clients for further information and being the first point of contact for some to manage escalations. Providing training on certain products, processes and the use of databases. Checking escalations, weekly reports and follow-up letters. Translating to and from Hungarian as necessary.

Summer Student

• Aug 2013 - Aug 2013

Course: Advanced Methods and Techniques in Plant Biotechnology● Gene expression analysis● Laser microdissection● Plant cell transformation● Enzyme assay● Protein expression analysis Course: Advanced Methods and Techniques in Plant Biotechnology● Gene expression analysis● Laser microdissection● Plant cell transformation● Enzyme assay● Protein expression analysis

Internship

• Jul 2013 - Jul 2013

● Learning how GMP and ISO 9001 guidelines are implemented at a pharmaceutical company● Introduction to sterile product manufacturing● Quality Assurance and Quality Control of sterile products● Organizing visiting production sites for fellow interns ● Learning how GMP and ISO 9001 guidelines are implemented at a pharmaceutical company● Introduction to sterile product manufacturing● Quality Assurance and Quality Control of sterile products● Organizing visiting production sites for fellow interns

Laboratory Practice

• 2013 - 2013

● PCR, electrophoresis● Vector design and in vitro transformation● DNA, mRNA isolation● Restriction enzyme digestion● Hybridization, ligation, ligation independent cloning ● PCR, electrophoresis● Vector design and in vitro transformation● DNA, mRNA isolation● Restriction enzyme digestion● Hybridization, ligation, ligation independent cloning