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Packaging Artwork Change Specialist

Business Type: Pharmaceutical Company
Job Type: Regulatory Affairs
Job Level: Not Specified
Position: Contract
Salary: Competitive + benefits
Location: South East
Reference: 17663/001
Closing Date: 31/05/12
Our client, a world leading pharmaceutical company, discovers, develops, manufactures and markets a wide range of innovative, value-added pharmaceutical products for both humans and animals around the world. They are currently seeking a contract Packaging Artwork Change Specialist for their Surrey site.

The contractor reports to the Senior Artwork Change Manager/SME, with personal responsibility for the change management process to approve new or revised packaging components for Clients products and to implement them to fixed regulatory timelines.

To work closely with key stakeholder groups, to coordinate Artwork approvals with personnel at the Client''s Affiliates. They will work in compliance with regulatory timelines to ensure that product supply is not impacted.
To co-ordinate the above activity using/working within the Clients electronic packaging artwork approval management system (ePALMS).
The Contractor is responsible for tracking and real-time transparency of the approval status of packaging components, in line with the EMA (European Medicines Agency) regulatory guidelines.
This role is responsible for initiation of Artwork Requests (PARS), and will coordinate across business lines to assure key regulatory timelines for Artwork implementation are met.
Following the initiation of the PAR process in the ePALMS system, the Contractor then tracks the approval status of packaging artwork components across multiple global markets (e.g. across the EU region - 28 country approvals). They are also required (as necessary) to respond to document requests from legal for product litigation/defence related to labelling.

Bachelor''s degree or equivalent in an appropriate discipline, plus related solid work experience.
Must be familiar with Regulatory environment, and have an understanding of labelling regulations and controls.
Must be able to interact with Client''s globally distributed Stakeholders in a professional manner.
PC skills including spreadsheet, database management are required.
Experience of working in a quality environment, strictly following SOP and working practices, and focusing on accuracy and a ''right first time'' approach to their work.
Familiarity with, and demonstrated use of electronic Artwork and Labelling Management Systems (eg ePALMS business system) or equivalent.
Strong, demonstrated project management.
In depth knowledge of manufacturing and manufacturing Plant processes/requirements.
Knowledge of Pharmaceuticals manufacturing preferred.

Diplomatic with strong interpersonal, writing and verbal communication skills required.
Excellent organisational skills. Must be able to handle a number of product artwork changes at the same time, with differing stakeholder groups.

BENEFITS OF THE ROLE: This Company that has been consistently recognised as one of the nation''s best employers offers state of the art R&D facilities and workplaces that have been designed to meet their employees'' needs with flexible hours, childcare centres, health and fitness facilities and sports and recreational opportunities. You can be assured of a competitive remuneration together with comprehensive and customised benefits and competitive, performance-based compensation.

Fforde is acting as a recruitment agency/business.

Labelling, regulatory, packaging, artwork, pharmaceutical, manufacturing, documents, contract.

Posted: 03/05/2012 | NPJ Ref: 81462
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