Transguard Group was established in 2001 and has diversified significantly, we lead in the fields of Cash Services, Security Services, Manpower Services, Facilities Management & Aviation. Transguard Group is the UAE’s most trusted business support and outsourcing provider and has a large, dynamic and culturally diverse workforce with 50,000 employees! We are currently recruiting for Labelling and Packaging Contractor for our trusted client . The candidate is to be based out of UAE.
This role 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
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.
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.
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 as required following final market review and signoff.
Uploads any locally reconditioned or repackaged Artworks into ePALMS using “dual role” system capabilities to assure correct Artworks are available for next revision cycle
Document management tools used for storage, retrieval, lifecycle management and tracking, of Labeling related secondary packaging components (e.g. ePALMS, GLAMS, BLUE, GDMS, Agile, PfLEET or similar systems).
Business Analytic tools used for tracking and reporting of product Labeling, Artwork or submissions (e.g. BI Reporting, Spotfire, Tableau, Business Objects or similar tools).
Document review, copy editing or proofreading tools (e.g. Docu-Proof, TVT or similar tools)
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 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.
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.
Strong demonstrated project management and 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.
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