Quality/Regulatory and Validation Officer

• Sep 2021 - Present

Masters Student

• Sep 2020 - Sep 2021

* Masters Degree in Pharmaceutical Regulatory Affairs * Currently holding the role of part-time childminder whilst completing a Masters Degree in Pharmaceutical Regulatory Affairs. Ensuring the responsible provision of care to children and developing within the Irish culture and English language. * Masters Degree in Pharmaceutical Regulatory Affairs * Currently holding the role of part-time childminder whilst completing a Masters Degree in Pharmaceutical Regulatory Affairs. Ensuring the responsible provision of care to children and developing within the Irish culture and English language.

Au Pair

• Aug 2017 - Aug 2019

- Gained invaluable experience as the primary caregiver to a child with Autism and global development delay disabilities. Received pertinent training from Behavioural Specialists and the child’s Therapists; developed skills in working with applied behaviour routines as such communication language and physical activities. - Built a strong trusting relationship with the host family through exceptional communication skills and the provision of feedback regarding the children’s daily activities, suggesting areas of behavioural focus. - Demonstrated exceptional flexibility and adaptability; working well in high pressured environments and adjusting availability as required. - Identified and assisted in the implementation of improvement areas within the care team.

Quality Control Analyst

• Sep 2014 - Jan 2016

Technical Skills: Working knowledge of instruments for measuring specs (Gravimetry, Volumetry, HPLC, CG, FTIR, PH-meter, K.F, UV-VIS, TLC, TOC)- Participated in routine analytical testing of pharmaceutical finished products for release into commerce, stability samples and under investigation batches.- Developed an in-depth understanding of quality and compliance metrics and concepts, following USP guidelines and in-house SOPs.- Performed API assay and related substance testing, content uniformity, dissolutions, blend uniformity by HPLC among a variety of analytical instruments. - Provided pertinent analytical support to the validation group.- Ensured the meticulous adherence to stipulated company SOPs and compliance with cGMPs. - Maintained proper documentation of laboratory data; carried out a vast administrative function including, complete testing, data evaluation, and SAP reporting.- Leveraged a natural flair for leadership and development; oriented and trained new employees and ensured the efficient training of hand over staff regarding validation processes within tight deadlines to expedite turnaround time of samples. - Maintained, calibrated, and managed the general maintenance of laboratory equipment under a quality assurance and standard operating procedures; responsible to calibrate the analytical scales on a daily basis prior to commencement of duties. - Supported various QC analytical method operations within a well-established pharmaceutical manufacturing organization.- Responsible for physicochemical analysis of pharmaceutical water for the end of year water system validation; this project required pristine laboratory procedures, attention to detail and a methodical approach to the testing which was conducted over a period of three consecutive days, all of which required absolute compliance. - Developed strong cross functional relationships with validation and production teams.

Quality Control Intern

• Nov 2012 - Aug 2014

Softwares: SAP for reporting , Excel, Internal Systems (Reference Library) - Provided integral support regarding the analytical testing of pharmaceuticals, finished products and raw materials.- Responsible for the sampling of pharmaceutical and potable water utilized in both chemical and microbiological labs and in the factory plant for production of pharmaceutical products - Conducted analytical physicochemical testing of potable and pharmaceutical water (use of TOC); demonstrated a keen willingness for cross functional collaboration; carried out the above mentioned testing for the microbiological lab. - Responsible for elaborating the data report for all water analysis, maintained the data archives (physical and electronic Excel spreadsheets) organised and generated final reports for the end of year water system validation.- Performed TOC analysis of water and cleaning validation in a different company, in times the equipment was defective. This ensured that all analyses were made in time of deadlines, instead of waiting for the equipment problem to be fixed.- Trained in the execution of operational equipment that required dedicated analysts (HPLC and CG); conducted foundational analysis.- Strived to excel regarding compliance and standard operating procedures and etiquette.