Andrea Wynne Email & Phone Number

Ireland

- Support provided to the product quality organisation as a subject matter expert of commercial product stability studies and GMP data management.- Leading and collaborating on projects, issue resolutions and investigations within the product quality team.- Working closely with a diverse set of functional groups, including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Quality Engineering, International Quality and Process Development.- Building and monitoring product stability studies within the quality system (LIMS), owning and handling product quality/stability data, and technical GMP documents.- Resolving day-to-day issues such as, logistic issues, product supply and forecast adjustments/variations.- Directly participating in and supporting site based GMP inspections.- Expertise in project management, time management and successful navigation skills within a varied team environment.- Keen attention to detail applied to conduct data review and reports.- Adeptly managing time-sensitive activities independently.

County Dublin, Ireland

- Sample management activities across the ADL site, such as, sample distribution, LIMS logging, shipment receipt and Quality Assurance reserve management.- Stability program related activities, such as, pulling stability samples, study initiations, review of stability study documentation and coordination between the stability specialist team and sample management.- Creating/owning, reviewing, and approving SOPs, sample plans and other GMP documentation.- LIMS, SAP and CIMS functions/transactions within the sample management remit.- Working and collaborating cross functionally with a high degree of flexibility.- Management and maintenance of site inventory of reference standards, assay controls, training, and verification samples.- Out of hours responder for sample management equipment (fridges/freezers/incubators).- Confirming and tracking sample shipments and temperature monitoring activities, to ensure timely andcontinuous supply.- Management/organisation of the team’s daily schedule to ensure completion of all tasks/processes.- Troubleshooting, solving problems that may arise and communicating with stakeholders.- Participating in audits, initiatives, and projects.- Introducing new techniques/processes to Quality Control and evaluating practices for compliance and continuous improvement.

County Dublin, Ireland

Responsible for the following:- Aggregate Reporting (PBRERs, PSURs, NDAs)- Signal Management (Case series reviews , Signal Assessment Reports and other signal management activities).- Clinical Overviews- Literature Review- Product Information review, assessment and update (PILs and SmPCs).- Responding to requests for information from the health authority, medical information department and regulatory department.

County Dublin, Ireland

County Dublin, Ireland

Performing assessment of adverse event case reports.Providing root cause analysis for any late reporting submissions.Management and prioritisation of individual workload while maintaining good documentation practices (GDP).Acting as back-up to Team Lead.Contribute to the development of PV training and carrying out training for any new starts.Highlighting any safety related issues to the attention of the management team.Experience working with PV safety database systems (Arisg and Argus).

County Kildare, Ireland

Manufacture and development of analytical device capable of measuring hydrogen in exhaled breath.Report writing.Professional presentations.Literature research.Time-management. Identified and developed strategies to ensure device success.Data analysis.Statistical analysis.Electrochemistry.

I carried out research for Bluebox Sensors Ltd based in Maynooth, which gave the company invaluable information regarding storage time and stability of their product. I was a lab demonstrator each year throughout the Ph.D and was responsible for and guided undergraduate students through various experiments. I advised and assisted them with techniques and the use of lab equipment. I worked for and supported the examinations office for the Maynooth examinations.I was responsible for undergraduate final year research projects and I guided the students through writing their final year thesis and presentation of their work.

Chapelizoid Industrial Est., Dublin 20

The manufacture of products required for customer orders.Product packaging and attachment of necessary documentation belonging to particular products were prepared.Effectively managed multiple orders and successfully delivered the specific orders to customers, achieving customer satisfaction.

The Ilac Centre, Dublin 1

Maintained the appearance of the premises and evaluated areas where products needed to be organised.Advised customers on a wide range of products.Answered the telephone and dealt with customer queries or complaints, achieving customer satisfaction.Used sales figures and best-selling product knowledge to give customers advice on what items to purchase.Maintained internal and external displays.Trained new employees to work in varying departments of the premises.Replenished stock and organised product deliveries, so that new products were readily available for customers to purchase.

Doctor Of Philosophy (Ph.D.), Bioanalytical Chemistry

The research carried out during the Ph.D involved the design, development and testing of specific analyte detecting sensors.

Bachelor'S Degree, Chemistry And Biology