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Gcp Auditors Level I

1 mese fa

Milano, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.**:
**As a QA Auditor you will conduct complex internal and external audits and process audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and client contractual obligations.**:
***:
**Summarized Purpose**:
**Conducts complex internal and external GCP internal and/or external audits and process audits verifying compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GxP practice activities in support of clinical development programs. Provides audit reports to management. Plans and delivers quality services for internal process audits and contracted quality assurance audits., internal site audits, laboratory and file audits for clients and projects.**:
***:
**Essential Functions**:

- ** Conducts and leads a variety of client, internal or **GCP** audits and process audits as requested by senior management**:

- ** Provides** GCP **consultation and support to PPD project teams and external clients Leads process audits and may participate as a co-auditor in more complex system audit.**:

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

- ** Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings**:

- ** Act as a lead for client with billable audits**:

- ** Provides mentorship and guidance to junior auditors**:

- ** This role will have a travel requirement of up to 50%.**:
**Education and Experience**:

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

- ** Previous QA experience in GCP area that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.**:

- ** Previous experience in other GxP areas welcomed.**:
**Knowledge, Skills and Abilities**:

- ** Thorough knowledge of **GCP** and appropriate regional research regulations and guidelines**:

- ** Demonstrated proficiency and led a range of project based or internal GCP audits and vendor audits to high standards required by management**:

- ** Excellent oral and written communication skills**:

- ** Willingness to travel**:

- ** 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/workload**:

- ** Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel**:
**Our 4i Values**:
**Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain **5 reasons to work with us**. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.**: