Thermofisher

24 сен

QA Auditor III (manual)

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Рекламный баннер: ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ЦЕНТР НАЦИОНАЛЬНЫХ ИНТЕЛЛЕКТУАЛЬНЫХ СИСТЕМ"

описание

Applicants must already have the right to work in the country of employment.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

задачи

*Competitive sign-on bonus considered for qualified candidates**

Position: We are actively hiring experienced GCP QA Auditors Level III and above!

Locations: Spain, UK and France (remote) Candidates must be located in one of these countries and hold the legal right to work.

Join us as a GCP Quality Assurance Auditor III/Manager and enhance our clinical auditing processes by ensuring regulatory compliance and quality standards.

Conduct and/or lead a variety of client, internal or GCP audits and regulatory inspections as requested by senior management

Perform directed site audits, facility, vendor and/or sub-contractor audits

Provide GCP consultation and support to project teams and external clients

Lead process audits and may participate as a co-auditor in more complex system audits

Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)

Serve as a knowledgeable resource to operational departments on audit or quality assurance subject matter

Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings

Travel will be required, up to 12-15 times per year (on average 1-2 times per month) across EMEA

требования

GCP Auditing

Investigator Site Audits

Other:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Thorough knowledge of GxP and appropriate regional research regulations and guidelines

Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management

Excellent oral and written communication skills

Strong problem solving, risk assessment and impact analysis abilities

Solid experience in root cause analysis

Above average negotiation and conflict management skills

Flexible and able to multi-task and prioritize competing demands/work load

Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel

Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

Frequent mobility required.

Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

Frequently interacts with others to obtain or relate information to diverse groups.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

Regular and consistent attendance.

условия

Work is performed in an office/ laboratory and/or a clinical environment.

Exposure to biological fluids with potential exposure to infectious organisms.

Exposure to electrical office equipment.

Personal protective equipment required such as protective eyewear, garments and gloves.

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.

навыки

gcp

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