Primary Function/ Primary Goals. Objectives:
Maintain quality department documentation systems and associated filing, logging and processing of documents and quality records.
Work with all functions within Abbott Nutrition Jhagadia to provide document control and related services, generate documents and records and communicate status.
The job holder is responsible to develop good documentation practices in the plant and should be responsible for document control of all the functions within Abbott Nutrition Jhagadia.
Major Responsibilities:
Perform Document Control activities including processing of Document Change Controls, Review, Approval, and filing of completed Documents in line with global requirements.
Maintain the various quality system files and associated documentation including change control, audits, training, etc.
Ensure adherence to Document Retention as per Abbott Policies
Conduct gap analysis for corporate and division policies, site level documents and regulatory requirements applicable to site and develop action plan to close the gap and mititgate risk
Ensure changed documents are processed in accordance with the procedures and final release in the Electronic Document Management System.
Ensuring the Periodic review of site documents are completed by respective site subject matter expert.
Ensuring the Multi Site Effectivity of global documents is completed by respective site subject matter expert.
Provide administrative assistance intra-departmentally for Regulatory and Quality Systems activities.
Provide documentation support to various inter-departmental teams and activities. Work with project team members and independently in support of documentation services needed to achieve planned deliverables and timeframes.
GDP -Audit &Training.
Provide necessary direct & indirect support for presnting required documents during internal or external audit.
Review other AN network site audit observation and prepared proper risk assessment for JH site
Replicate document change control best practice from other AN network site to JH site.
Education:
Background:
Effective interpersonal, communication & influencing skills
Ability to work independently and manage assigned responsibilities and projects.
Understanding of Quality systems ISO 9001/ISO 22000/ FSSAI /BIS / Risk Assessment and exposure for HACCP analysis is desirable.
Experience in processing, reviewing and filing hard and soft copy documents, preferably within the quality department in a Nutiritonal or similarly regulated industry
Excellent organization and filing skills, both hardcopies and electronic file management, consistent attention to detail
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email [email protected]
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