Project Management Co-ordinator - North Moreton, United Kingdom - Eurofins UK PSS

Eurofins UK PSS
Eurofins UK PSS
Verified Company
North Moreton, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.

Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Eurofins Professional Scientific Services (PSS) is part of the Global Eurofins Business with over 61,000 employees. Eurofins PSS recruits full time scientists on permanent positions at client sites working collaboratively side by side with clients at their site on their projects and helping to develop and bring new medicines to patients to help improve and save lives.

Job Description:


This is a fulltime, permanent position working a 35 hour week flexibly Monday - Friday between 07:00 - 19:00

  • Supports delivery of clinical supplies through effective management of assigned clinical project. Liaise with CSO Drug Supply Managers (DSM) on aspects of clinical supplies packaging and labelling design, on production scheduling options that enable ontime delivery of desired supplies, SAP demand entry, SAP material creation and on related purchasing activities.
  • Liaises with Drug Product Science & Technology (DPST) and Analytical where necessary to ensure required method development, standards, stability testing and associated aspects are available to support clinical supply activity.
  • Manages multiple projects. Responsible for coordinating deliverables of assigned projects (e.g. product, code and label text) with production schedules. Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Identifies and reports issues to appropriate levels of management in a timely manner.
  • Generates internal packaging and labeling and label print production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Responsible for the creation and/or release of BOMs and process orders for assigned projects within SAP, including relevant checks on order accuracy, etc.
  • Drives collaboration with CSO, Analytical and Quality colleagues to ensure ontime testing and release of assigned projects.
  • Sources labels from approved label vendors. Supports the CSO outsourcing strategy through monitoring compliance with applicable Master Service, Technical and Quality Agreements with identified vendors and completion of vendor quality metrics.
  • Ensures regulatory and GMP compliance of activities in assigned areas of responsibility, through monitoring and management of vendor performance and reporting any deviations immediately to the appropriate line management and Quality unit.
  • Supports cost efficiency of outsourced operations through leverage of project volume driven discounts, consolidation of outsourced activities where appropriate and the use of best value suppliers.
  • Supports GMP compliance through conducting assigned investigations for deviations, contributing to maintenance of the CSO Risk Register.
  • Authors new and/or reviews existing procedural documents. Ensures processes remain in compliance with current GMP, superior BMS procedural documents and are aligned with relevant business practices.
  • Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
  • Participates in assigned training including CGMP and safety training. May provide staff training as identified.
  • Ensures project management and outsourcing operations are sustainable at all times through development of self and others such that technical support is maintained across the breadth of services provided.
  • Responsible for checking BOMs, change and process orders for other Project Management Coordinators.
  • Executes TECO transaction on completed process orders. Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use. Liaises with Quality Assurance to secure release of finished supplies.
  • Manages auxiliary labeling requests and outsourced packaging and labeling at an approved vendor.

Qualifications:


  • BSc degree in Life Sciences, IT or related field or equivalent qualification. Significant relevant experience may be considered in lieu of educational qualifications
  • Some experience in clinical supplies project management.
  • At least 2 years relevant experience working in a GMP regula
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