Nichola Thomson Mba Email & Phone Number

Scarborough, Qld, Au

Melbourne, Victoria, Australia

Responsible for managing and leading the validation /projects team and effectively running the day to day operations. People management: Responsible for leading the validation/ projects team including staff reviews, and coaching staff Quality Management: Ensuring staff are following the PICs and FDA regulations . Working knowledge of the USP, BP, JP, EP compendial requirements Ensuring all lab equipment, procedures and documentation is up to date and compliant. Project Management Overseeing validation projects including the installation and implementation of a Liquid Particle Counter and sonicator Liasing with project management staff for the duration of projects Liasing with QA staff for project documentation revie

Melbourne, Australia

With 28 direct reports I was overall accountable for the operations of the Pathology Laboratories including Sample Reception, Biochemistry, Haematology, Microbiology an Molecular departments. Operations management: Conducting review of laboratory current workflow and floor plan to optimize efficiency. Conducting review of resources across shift v's sample numbers for efficiency Conducting review of data entry process to reduce errors and increase efficiency Quality Management: Overseeing review of all Microbiology Laboratory methods to ensure efficiency and compliance with NATA and CLSI regulations. Ensuring Quality systems are implemented and maintained within the departments in accordance with NATA regulations. Overseeing the preparation of the departments for NATA and internal audits. Project Management Managing setup of Clinical Projects: liaising with customers, project budgeting, quote development, liaising with external laboratories where required, liaising with IT and accounts to organize billing. Managing Clinical Project in lab: Resource requirements, costings, timeframe, monitoring project. People management: Responsible for leading a team of 29 Pathology staff from Microbiology, Biochemistry, Haematology, Molecular and Specimen reception departments Staff management including onboarding new staff, personal development plans, coaching and appraisals.

Dun Laoghaire

Accountable for the operations, quality management and continuous improvement of the Microbiology department, and accountable for sterilisation.Project management: • Conducting review of all Microbiology Laboratory Operations to improve efficiency• Project Managing Cobalt 60 replenishment process • Project Managing relocation of Microbiology Laboratory Responsibilities: • Overall in charge of the Microbiology department in which a wide variety of analytical techniques are carried out including bioburden and endotoxin testing, environmental monitoring, sterility dose audits, growth promotion and bacterial identification.• Managing projects in both Microbiology department and Sterilisation. • Overall responsible for validation and compliance activities related to Microbiology in QA and the plant • In-depth disciplinary knowledge; leveraging business acumen and subject matter expertise. • Providing thought leadership, guidance and advice in areas of Microbiology and Sterilisation. • In-depth understanding of company goals, customer requirements and knowledge of competitor practices. Thorough understanding of BD business priorities, strategy and direction. • Continually reviewing Standard Operating Procedures and keeping up to date knowledge of relevant Standards • Ensuring compliance to GMP throughout plant • Conducting safety audits in the Microbiology lab and sterilisation department • Ensuring timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures. • Keeping abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing. • Approval of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.

Dublin

Responsible for the operations management, business development and quality management of the department. Achievements: Business development:  Researched, developed and launched a new B2C service in partnership with the marketing department. Researched, developed and launched several new B2B services in partnership with the Marketing and Quality departments including : PCR for N. gonorrhea and C. trachomatis ◦ Quantiferon TB Gold ◦ Parasitology ◦ Norovirus Project management:  Project managed the changeover from CLSI to EUCAST standards. Project managed the introduction of new services within agreed timeframes. Quality management:  Developed, implemented and maintained Quality Systems within the department in accordance with ISO15189 accreditation standards. Successfully achieved and maintained accreditation through 6 successful INAB audits.  The new services achieved accreditation first time within these audits.Operations management: Developed a system to improve stock management and information management. Implemented Lean Six Sigma processes. Worked with IT department to interface department analysers and implement new LIMS system. People management: Successfully managed and developed 11 members of staff over 4 years including the on boarding of new staff members.  Trained staff members in new techniques and processes. Successfully motivated staff to meet deadlines in the development of new commercial revenues.

Worked in all areas of a large, busy microbiology laboratory.Trained several staff membersValidated DS2 automation for Rota and Adenovirus and C. difficileHelped with updating SOP's

In charge of 17 members of staffTrained Medical Scientists and Trainee Medical Scientists. Improved the quality of the department in accordance with accreditation standards

Worked in all areas of the microbiology department including blood cultures, sputums, stools, urines, MRSA screens, swabs.Participated in the out-of-hours rota.Participated in external and internal quality control.Assisted in the training and supervision of Trainee Medical Scientists. Deputised for the head of department

Responsible for overall use, maintenance, QC and calibration of the Olympus AU600, AU640, AU400, AIA1800, Blood gas analyzers and VIDASResponsible for near patient testing of Blood Gas Analyser including medical staff trainingResponsible for liaising with other diagnostic and reference laboratoriesParticipating in CPD.

Responsible for the overall organizing and allocating work within the department, including bacteriology and serology.Supervision and training of Biomedical Scientists and Junior staffMaintaining good stock controlMaintaining departmental statisticsGiving infection report at monthly Infection Control meetings

Worked in all areas of the microbiology department including blood cultures, sputums (including TB work), stools, urines, MRSA screens, swabs and virology/serologyParticipated in the on-call rota.Participated in external and internal quality controlAssisted in the training and supervision of Laboratory Assistants.

Executive Mba, Executive Leadership

Marketing Management; Effective People Management, Information Management, Operations Management, Project Management, FInance Management.

Msc, Biomedical Sciences

Bsc (Hons) Degree, Biological Sciences