Nicola Brady describes the busy and satisfying job of QA & Compliance Specialist with Odyssey VC and Compliant Cloud, through the lens of one day.
By Nicola Brady
I joined Odyssey VC in April this year as a Quality Assurance & Compliance Specialist, looking after the Quality Management System for the company and providing QA & for Computerised System Validation (CSV) and Cloud Service delivery. I work from home in Galway 4 days a week and travel to the Sallins office once a week.
My day starts early thanks to my 11-month-old daughter who likes to wake at 5.30am lately. We get up, get dressed, eat breakfast and get ready for the day. My husband and I usually alternate but it is my turn today. I work from home on Mondays, so I walk her across to creche for 8am and then its time to start my working day.
Odyssey VC have supplied all the technology, systems and hardware so that I can work effectively from my home office. At 8am, with a strong coffee in hand, I log on and start my day. At the start of the week I like to review and print my calendar and review emails received that may require urgent action.
I spend the first part of the morning providing my input to a new procedure and templates being created to standardise the project management process at Odyssey VC. These templates will ensure a streamlined and consistent approach to the management and documentation of projects both in-house at Odyssey VC and at customer sites. I provide my comments electronically, notify the author and schedule a follow-up meeting to discuss updates.
All Odyssey VC suppliers are evaluated and assessed prior to approval for use. I have received a completed Supplier Questionnaire with supporting documentation from a potential supplier. I review the completed documentation to determine if the answers are satisfactory or whether additional information is required. I review the supporting documentation to confirm that it supports the required elements of the Supplier Questionnaire. A number of follow-ups are identified so I issue a communication to the potential supplier requesting additional information. I then schedule a meeting with IT management to go through the questionnaire and determine suitability for approval.
A change control meeting is scheduled next to allow the deployment of a new system into a production environment. We discuss the scope of the change, functionality that will be enabled and the tasks that are required to control the change. The change owner updates the document and circulates to the Change Control Board members for pre-approval. I document my approval and return a scanned copy.
I am scheduled to deliver Good Documentation Practices (GDP) training to new hires this afternoon so I refresh myself on the training material in advance of breaking for lunch.
As I am working from home I feel that it is important to get some fresh air each day, if possible, so I take a quick stroll around the block and then grab a quick bite.
I commence GDP training with the new hires over SKYPE after lunch. All Odyssey VC employees, irrespective of their role and level in the organisation receive GDP training to ensure that they have an understanding of the importance of data integrity and how to apply GDP rules. We work through signature requirements, date formatting, management of errors and show examples of what not to do.
As part of the CSV graduate training program we conduct extensive live document reviews. The graduates are issued with copies of executed CSV documentation and background reading material from previously executed projects. The graduates perform a review of this documentation individually and then as a group we will and discuss issues and observations. I had previously issued a software factory acceptance test (SFAT) document set to a group of CSV graduates and today I am reviewing and discussing the findings with the group. Our discussion includes general GDP, requirements traceability and fault reporting. This is one of several live document review exercises the graduate group will complete prior to being deployed to a customer site or project.
I am delivering an optional change control overview session to all staff tomorrow as a result of recent changes to the change management process at Odyssey VC. I prepare a presentation to cover the why and how changes are controlled as well as industry examples of uncontrolled changes and the associated impact.
I have a quick call with another member of the QA & Compliance team in Sallins to discuss the status of ongoing QMS activities including document updates, nonconformances and CAPAs and internal audit actions.
I will be travelling to the Sallins Office tomorrow, so I make a plan for the next day before I head across to collect my little one and resume my second job as Mommy!