Adhere to and complete all equipment documentation. This includes, but is not limited to: Standard Operating Procedures (SOP) Equipment Training Documentation, Metrology Specification Requests (MSR) Equipment Qualification Documents (e.g., IOPQs, job tasks) Other equipment validation documents (e.g., risk assessments, URS, etc.) Supplier Approval Request Forms (SARF) Total Management System (TMS) Forms, Work Orders, Coordinate with in house or vendor maintenance and qualification activities: Work with Operations to determine appropriate time frame for maintenance, Schedule maintenance with Facilities Management (FM) Escort vendors during maintenance and qualification activities, Ensure vendors meet GMP compliance requirements (i.e., approved supplier, training documents obtained, etc.) Manage “Do Not Use” signs to ensure instrumentation downtime is minimized, Where required arrange for the installation and set-up of new equipment. Complete GMP quality records to an appropriate standard related to equipment failures and changes: Deviations, Change Controls, CAPAs, Audit Comments, Compose documents from concept, Write IQ/OQ/PQ documents for internal execution, Compose SOPs and Policies as QDMS author Serve as the subject matter expert (SME) and main point of contact for equipment / process Arrange purchases for GMP EM Team or Operations Gather quotes / contracts from appropriate service providers, Execute PO Requisitions / ePro submissions, Approve documentation completed by other associates with instrument knowledge confidence, Engage in improvement initiatives towards a singular process for all EM processes and documents. Work on process harmonization across GMP sties (SOPs / IQOQPQ documents) Coordinate / collaborate on continuous process improvements across GMP sites, Assist Global Business Technologies (GBT) and other areas of Global La, Prioritize GMP EM Team function, Prioritize daily responsibilities of associates according to business needs, Determine associates area of GMP EM responsibility and determine cross training opportunities. Need to have in-depth understanding of Health and Safety policies, Company Policies and Procedures, a working knowledge of ISO (accreditation and application), and an in-depth understanding of the GxPs processes.
Managing and supporting the Equipment and Metrology team. Looking after the whole life-cycle of scientific equipment from purchasing to archiving stages; acting as UK segment TMS administrator and support 8 TMS teams across UK and EU . Co-coordinating all equipment documentation. Supporting internal and external audits and clients. Overlooking completion of the equipment purchasing projects. Writing performance and result reports, KPIs, 1-2-1 meetings, weekly team meetings, monthly management meeting. Training others on TMS and equipment processes.
15 years and 10 months
Medical Technical Institute -Medical Laboratory Officer, People Management course
I have progressed from a lab technician, administrator, and supervisor to my most recent role as Manager of the Equipment Management Team
I built a successful team. They are all great individuals SMEs with different strengths and expertise.
I love people succeeding. With the right training and support people are striving to personal and professional success. Also love when we release medicine to market which ultimately saves people's lives.
-Not enough time in the day.
-Fast pace industry where processes are changing on regular bases - the globalization of the processes could take long time.
-The disciplinary procedures.
Excellent communication, fast learner, customer and process focused, proactive, self motivated with drive to results, capable to work with teams as well as individual contributor.
Resilience, focus, don't give up one day it will all make sense
I was trained phlebotomist, during the blood draw person fainted, I had to give the person first aid while the needle was still in his arm.