Packaging & Labeling Artwork Specialist

• Initiation and “build” of Pfizer Artwork Requests (PARs) in collaboration with markets, assuring all required information, specifications and/or supportive documentation is available for plants/Artwork Centers to execute the production of product labeling related packaging components
• Coordinating Artwork Change Control logistics across multiple Pfizer departments to assure Regulatory timelines for implementation are met and that product supply is not interrupted
• Tracking Artwork Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects
• Support for large-scale Artwork Change Control projects with broad portfolio impact under the direction of more senior ALIM staff
• Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings and potential process improvement recommendations
• Retrieve documents and/or generate reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to labeling in distribution)
• Liaises with markets and stakeholders to gather all necessary information to initiate and “build” PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet implementation requirements
• May create Editor’s Copy (EC) for select markets depending on language(s) involved and specific “custom” services negotiated with markets in line with local SOPs
• Liaises with GRO GLM/IL functions, GRS/PCOs and PGS PCOs, or demand management lines to coordinate any unique factors that need to be considered
• documents agreement on Artwork timelines across stakeholders
• escalates any issues/concerns within ALIM functional line and/or relevant leadership for adjudication as necessary
• Performs ePALMS “Market Coordinator” role, according to agreed timelines and established procedures

• Bachelor’s degree in an appropriate discipline, plus 4-6 years work experience related to Artwork Change Control processes
• Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging & distribution processes as well as a basic understanding of Artwork & Labeling regulations and controls
• Must be able to collaborate with cross-functional Pfizer teams, negotiate across globally distributed affiliates and manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner
• Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required
• Strong written and verbal communication skills required
• Strong English language skills are required of non-native English speaking colleague to enable global interactions
• Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed
• Demonstrate organizational skills
• In-depth knowledge of PGS manufacturing and site processes/requirements
• Must have capacity to solicit input in ambiguous business situations, resolve conflicting feedback and make appropriate business decisions
• Attention to detail and ability to research and respond to audit/inspection queries
• Ability to travel (Domestic and/or International) is required

Multi-lingual skills are highly desirable at all levels