QA Auditor II

Work Schedule Other

Environmental Conditions Internal

Job Description

You will find that every role at Thermo Fisher Scientific is meaningful and impacts the world in a positive way. Come help our fellow colleagues achieve our Mission – help our customers make the world healthier, cleaner and safer. Career opportunities here allow our people to develop and implement their aspirations as well as take science a notch higher by discovering, designing and delivering life altering products. Our work is from laboratory, digital and decentralized clinical trial services with our PPD clinical research department that does clinical trials in over 100 countries and avails new structures for clinical research activities. Your desire to provide quality and accuracy will address health challenges that people and society need today for healthy living and also in future.

There is an opportunity for the position of QA Auditor II within our clients’ establishment for the EMEA region. This is a permanent full-time position. Country location preferred: UK

Role responsibilities

Develops audit policies, plans, and programs, prepares work papers, gathers evidence and conducts consent internal and/or external audits to determine the adequacy of the internal quality assurance systems, processes, standards and global regulations as well as any contractual obligations for quality assurance. Recognizes circumstances that may or do affect internal or external quality and or regulatory compliance, helps to pinpoint the causes of comformities and assists in finding ways to solve the problems. May conduct review of technical documents and other GxP related works in relation with the project work or company procedures. Provides final uncontrolled audit reports to the management. Plans and executes projects and other activities to provide clients with projects and other factors meeting a billable quality standard.

A day in the life:

Conducts and or coordinates various GxP audits and/or regulatory inspections utilizing clients and/or projects as needed directed by senior management. Carries out directed site audits, facility and vendor and or pre sub-contractor and subcontractor audits. Delivers GxP advice and assistance to project staff and clients. Takes charge of process audits and is involved as a co-auditor in the more intricate system audits. Carries out any non-ITQA activities or audits e.g. QA audits of databases, clinical study report QA audits, QA of tables with sample results, and nadelie on process upgrades. Acts as an important contact for operational areas regarding audit or quality assurance knowledge.

Presents audit outcomes, findings and related information during departmental, internal operational, or client oriented meetings.

Education and Experience

Bachelor’s degree or an equivalent and corresponding recognized educational/ training qualification

Traditionally does quality assurance work that gives knowledge, skill, and ability to do the work that will range from 2 years and above

GCP/Auditing Experience

It is required in some cases that an individual has a qualification which shall be determined by an academic institution or a professional body and such a qualification would be in combination of education, training and or exposure of the individual to the field of work.

Knowledge Skills and Abilities

Familiarity with GCP

Experience working in GCP Environment

Auditing experience

Some overseas trips (25%)

Our 4i Values: Integrity – Innovation – Intensity – Involvement

We will welcome any candidate who shares our 4i values and more so is interested in speeding up the body healing agents with regard to the fiercest health issues in the entire world, please send your application – all your application are cordially welcome!