Packaging and Labeling Artwork Implementation

3 weeks ago

กรงเทพมหานคร, Thailand Pfizer Full time

JOB SUMMARY

Colleague fundamentally performs the ePALMS system “
_Market Coordinator_” role in close collaboration with the Global Regulatory Affairs (GRA) Strategy functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a Subject Matter Expert (SME) centralized “hub” capacity and in some cases, may perform Regulatory Strategist roles & responsibilities where specific tasks are delegated and in line with local and global SOPs/Work Instructions.

As a seasoned “Market Coordinator” within ALIM these colleagues perform all activities of their more junior level peers including:

- Initiation and “build” of Pfizer Artwork Requests (PARs) in collaboration with local markets, assuring all required information, specifications and/or supportive documentation is available for plants/AWCs to execute the production of product Labeling related packaging components.
- Negotiating Artwork Change Control logistics across multiple Pfizer departments (as well as multiple markets) 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 as well as broader regional or ALIM department deliverables when required. Accountability for Final Label Content rests with the PCOs or functions creating content.
- Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings, identify opportunities for continuous improvements and prepare formal recommendations to ALIM leadership when appropriate.
- Retrieving documents and/or generating 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).

However, incumbents may be tapped to represent ALIM on various cross-functional projects, or sometimes lead ALIM continuous improvement teams. This could involve coordination of activities of other ALIM staff or contractors for the duration of the project.

JOB RESPONSIBILITIES- 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 mínimal 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/ILG functions, GRA PCOs and PGS AWCs, 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, by performing the following activities, which include:
- Evaluates content of Labeling updates and raises potential issues with GRA, PGS or relevant local markets as appropriate to minimize impact on schedules.- Evaluates PGS sites impacted by Labeling updates.- Initiates PARs in collaboration with assigned market(s); ensures attributes (system metadata) are correct, and ensures all relevant Regulatory documents are included and routed for any shared packs, assures that agreed upon content is received in appropriate format and is either reflected in a combined EC or as a separate EC for each market according to regional agreements and relevant job aids.- Uses Biopharmaceutical Packaging & Artwork knowledge, in combination with Trade Dress Style Guides, Country Specific Requirements and/or other appropriate guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs; escalates issues or concerns if/as needed.- Sends PARs to all relevant PGS sites; monitors and follows up on any aging PARs as needed.- Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed Artwork against EC is completed using appropriate tools; escalates anyissues, questions or errors within ALIM functional line or appropriate markets for adjudication as needed.- Initiates, manages and tracks any necessary rework.- Identifies appropriate Market Approvers for Packaging Artwork and electronically routes for approval using ePALMS lifecycle management; monitors progress and follows up as needed with appropriate PGS AWCs or GRA PCOs to assure agreed timelines are met and any Regulatory content issues that arise during the approval process are addressed.- Tracks and communicates final approved labeling to list of relevant departments and stakeholders following final market

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