Senior Quality Process Specialist

ICON

Sofia, Bulgaria

About the role:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

What will you be doing as Senior Quality Process Specialist:

Perform tasks relevant to the assigned Quality & Compliance function including but not limited to two main activities:
- Conducting Snapshots - Internal Quality Assessments;
- Fulfilling role of Q&C Business Partner during the SOP Harmonization.

What is means:

Provide support to all roles for EDMS activities, Documentation guidance, Training identification and Cross SOP Harmonization workstream communications;
Perform review of relevant study data as Trial Master File and other relevant data source;
Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines. Understand key business drivers; uses this understanding to accomplish own work;
Build knowledge of the company, processes and customers;
Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training;
Assume additional responsibilities, which are directed by the Q&C Manager or higher;
Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance;
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

To be successful in the role, you will ideally have:

Background in medicine, science and/or other relevant discipline and appropriate experience;
Experience within Clinical Research Environment (e.g. CRA, Data Management) an advantage;
Ability to review and evaluate clinical data/records;
Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients;
Detailed understanding of drug development and clinical trial process;
Good problem resolution skills;
Good planning and organizational skills with the ability to multi-task.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job