Label Project Senior Coordinator - Conwy, United Kingdom - ICON plc

ICON plc

Verified Company

Conwy, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Primary activities

Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate safety requirements to meet exacting standards defined by the client, the FDA and EU or other international regulatory agencies.
Coordination of Translation Requests
Generation of Clinical Label Proofs with CLPG
Liaise with countrylevel Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements, etc.
Maintain Label Translations library
Interpret clinical study design and Clinical Supply Strategy (CSS)
Design and verify label models
Coordinate MLBL manufacturing at vendors
Perform visual inspection and accountability for label proofs, clinical labels and RCE's
Provide detailed analysis of issues and collaborate for creative problem solving
Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
May represent Clinical Packaging on internal or crossfunctional teams. Will undertake and lead specific projects within the group on as needed basis
Participate as necessary in complaint and deviation investigations with a focus on true root cause, and creation of appropriate Corrective and Preventative actions (CAPA's). Drive CAPA's to closure.
Train Label Project Coordinator Level I team members and remain proficient in appropriate systems and software
Responsible for the physical facility and good housekeeping practices within their area.

Requirements:

BS/BA or appropriate combination of education and relevant practical experience

Working knowledge of Packaging Operations and related work centers

Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution

Strong attention to detail

Strong verbal and written communication skills

Strong organizational skills, ability to prioritize and ability to multi-task

Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint).

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people.

That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.