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Packaging Artwork Change Project Manager

Eingestellt von Synectics

Gesuchte Skills: Support, Client

Projektbeschreibung

RESPONSIBILITIES:
Liaise with clients European country offices in coordinating regulatory new or updated activity for packaging artwork labeling for client products.
Communicate/co-ordinate with key stakeholder groups for documentation of labeling 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).
Will be managing modification of packaging artwork
Raise and coordinate packaging artwork change controls in the artwork systems according to agreed timelines and established procedures, by performing the following activities: Support Affiliates with initiation of electronic artwork requests, ensure accurate entry of required data and that all relevant regulatory documents are attached and routed for approval.
In a timely manner, communicate with Affiliates and Manufacturing to ensure agreed regulatory timelines are met.
Evaluate content of labeling updates and raise issues
Develop and maintain relationships with relevant stakeholders.
Use pharmaceutical packagingstorage, retrieval, life cycle management and tracking of labeling artwork for packaging components in a business enterprise system
Bachelor's degree or equivalent in an appropriate discipline, plus related work experience (2-4 years).
Must be familiar with Regulatory environment, and have an understanding of labeling regulations and controls. Must also have knowledge of manufacturing.
Must be able to interact with client's globally distributed stakeholders: country offices, manufacturing sites and artwork center personnel in a professional manner.
PC skills including spreadsheet, database management are required.
Quality/proofreading background is strongly preferred.
Diplomatic with strong interpersonal, writing and verbal communication skills required.
Experience 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 or equivalent.
Excellent organizational skills. Must be able to handle a number of product artwork changes at the same time, with differing stakeholder groups.
Strong, demonstrated project management experience and expertise
In depth knowledge of manufacturing and manufacturing Plant processes/requirements. Knowledge of Pharmaceuticals manufacturing preferred.
Bilingual candidates preferred.
Must have capacity to make appropriate business decisions when facing uncertainty.

Projektdetails

  • Einsatzort:

    Collegeville, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Synectics