Artwork Impletementation Specialist - Tadworth, Surrey

  • Salary: Up to £24.64 per hour Ltd
  • REF Number: 00044342
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 10.01.2019
  • Sector: Non-Specific
  • Location: South East
  • Discipline: Regulatory Affairs

Lucy Stendall at CK Group is recruiting for an Artwork Implementation Specialist to join a company in the Pharmaceutical industry at their site based in Tadworth, Surrey on a 12 month contract basis.

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

The Company:

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:

The role will be based at our clients' site in Tadworth, Surrey. Tadworth is a large suburban village in Surrey in the south-east of the Epsom Downs, part of the North Downs.

Accountabilities:

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 Packaging 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 business system (ePALMS), the Contractor will then track the approval status of packaging artwork components in the EU region - max 28 country approvals. They are also required (as necessary) to respond to document requests from legal for product litigation/defence related to labelling.

Duties and Responsibilities:

  • Liaise with European Country Offices in coordinating Regulatory new or update activity for packaging artwork labeling for Client products.
  • Communicate/co-ordinate with key stakeholder groups for documentation of labelling artwork timelines
  • Liaise with Research Strategists on target dates for artwork completion on behalf of the Country Offices, and in conjunction with Manufacturing (working to SOPs/best practice guidelines).
  • Raise and coordinate packaging artwork change controls in the Artwork system (ePALMS) according to agreed timelines and established procedures, by performing the following activities:
  • Evaluate content of labelling updates and raise issues with the EU ALIM Lead and the Regulatory Strategists as appropriate.
  • Develop and maintain relationships with relevant stakeholders in WSR and PGS.

Your background:

  • Bachelor's degree or equivalent in an appropriate discipline, plus related work experience
  • Must be familiar with Regulatory environment, and have an understanding of labeling regulations and controls.
  • Must be able to interact with Client's globally distributed Stakeholders: Country offices, Manufacturing sites and Artwork Centre personnel in a professional manner.
  • 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 Labeling Management Systems (eg Client ePALMS business system) or equivalent.

For more information, please contact Lucy Stendall on 01246 457733 or email pharmacontracts@ckagroup.co.uk. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44338 in all correspondence.

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