Job Description

JOB DESCRIPTION:

This individual is the primary contact within the working team (GLO Manager, Label Specialists, Affiliate Regulatory, Affiliate Marketing, Affiliate Nutrition Science, R&D, Plant & Project Management Group) for planning, start-up, and execution of the label development activities through the label review system and ensures labels are reviewed, approved and completed.

The individual serves as the primary reference for product labeling and as such, evaluates proposed labeling changes and implements the changes, and develops the product label as prioritized by the appointed steering committee or project management group.

The individual ensures that the label development process flow is adhered to and serves as the primary contact for external customers such as Artwork agencies, translation agencies, and print suppliers.

CORE JOB RESPONSIBILITIES

Prepare and collate label development information required to initiate label development start-up activities.

Complete label development activities required to promote label projects from review to approval phase.

Responsible for selecting appropriate job packet workflow and assessing all applicable reviewers(s) and approver(s).

Ensure all appropriate documents are within the label job packet in the designated quality (Change Control) system.

Responsible for the accuracy and completeness of the job packet.

Primary contact for labels that require third party translation and request for translation service from third party translation agency as applicable and retain translation files and document records.

Work with and notify Regulatory contacts at the Affiliate level of label readiness for MOH submission.

Work with Plant Contacts to coordinate the implementation of the final label for product manufacturing.

Approve final color proofs as applicable.

Collaborate with Plant Label Control to ensure barcode type and commodity numbers meet country requirements.

Serves as GLO subject matter expert and to provide training as applicable for the label review system.

To collaborate with the Project Management group to meet committed product launches by ensuring label issues are resolved in a timely manner.

Review label development documentation for accuracy and compliance to current policy, process, and procedure.

Supervisory/Management Responsibilities

Define the size of the organization this job is responsible for as well as the level of the positions reporting into this job.

Interacts with GLO, Commercial Product Managers, Marketing Managers and Executives, Regulatory Managers, Affiliate QA Managers, Project Managers for labeling project management.

Work with Plant Quality Systems/Label Control for project completion.

Liaise with vendors for services.

Indicate the reporting relationships, products, budgets, throughput, level of contacts (internal and external)

MINIMUM QUALIFICATIONS

Minimum Education - Bachelors of Science/Engineering

Education Level Major/Field of Study Bachelors or Masters

Food Science, Nutrition, Dairy science or related discipline OR

Print media, Packaging, or related discipline OR

Supply chain, industrial engineering, or related fields

MINIMUM WORK EXPERIENCE

Experience

Experience Details At least 3 to 5 years of relevant experience.

Preferred Experience: Quality Management Systems, Regulatory Affairs, Quality Assurance, Operations.

Good practical knowledge of GDP in the food/pharmaceutical industry

Basic knowledge of regulations and standards affecting nutritional products. Understanding of the labeling process (initiation, development, and approval coordination)

Working exposure and understanding of artwork publishing/printing process

Relevant experience or an equivalent combination of education and work experience

Team player with imitative, drive, good communication skills

Ability to adapt quickly and effectively to shifting priorities

Able to effectively communicate with working teams, other functional teams, and other external customers (translation agency, print suppliers)

Ability to work with minimal supervision. Independently gathers resources and information needed to complete label projects Able to read and write English and be competent in at least one other Asian language.

Scope & Accountability

Quality & Compliance

Labeling activities and their related labels/documentations must not contain errors that will affect the quality of the product. Failure to provide accurate labeling may result in a customer notification, a product recall, material destruction, product rework, and delay in critical product launches. All of these results cost Abbott and its affiliates in terms of customer satisfaction, monetary cost, corporate image, relations with regulatory agencies, employee time, etc. After the label coordinator approves the label it goes out to the customer. He/she is the last person to see it prior to use on the product

Cycle Time/Schedule accountability:

Labeling and its related documentation for new products or revisions to existing products must be completed on schedule and based on agreed Key Performance Indicators (KPIs). Not meeting this responsibility will result in a delay in new product introduction, which can have a far-reaching effect, in sales dollars.

The salary for this role is between: N/A

JOB FAMILY: Operations Quality

DIVISION: ANSC Nutrition Supply Chain

LOCATION: India
Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott