Medical domain Labeling & Packaging Document Control Specialist

Greetings from Maneva!

Job Description

Job Title            -  Medical domain Labeling & Packaging Document Control Specialist

Experience       -  5 - 10 Years

Location            -  Bangalore

Notice               -   Immediate to 15 days

Requirements : -

• Manage documents to support Labeling Development in compliance with  ISO, cGMP, and FDA guidelines, working within established formats and templates.
• Change  control exp through Documentum / Ifs / Livelink / Master control /
• Complete Engineering Change Requests for Global Labeling & Packaging.
• Initiate the collaborative review process and assist document users with inquiries and research.
• Track documentation through the entire development process while adhering to strict timelines, maintaining revision control, maintaining change lists, and managing reviewers.
• Expedite change request consideration and approval processes including coordinating reviews by stakeholders of project change requests, managing stakeholders and approvers for timely response on change management requests, and maintaining comprehensive change management files and documentation.
• Effectively communicates activity status, issues, and mitigation plans with key stakeholders
• Identify areas for improvement (e.g., processes, styles, formats), and execute continuous improvement initiatives.
• Maintain a high level of quality, clarity, and consistency for all documents.Locate, organize, and maintain department files, databases, and spreadsheets.
• Organize and create controlled labeling or packaging documents / library of documents of a moderate complexity.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

If you are excited to grab this opportunity, please apply directly or share your CV at  [HIDDEN TEXT]  and  [HIDDEN TEXT]

Skills Required

Medical, Iso, Microsoft Office, Strong Interpersonal Skills, Livelink, Documentum