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

• Knowledge of Microsoft Office's suite of products , 3+ yrs. of hands on exp in medical device document controller role
• Strong self-motivation and ability to work independently and in a team environment.
• Strong follow up, organization and prioritization skills.
• Excellent communication skills, both written and verbal. Strong interpersonal skills: ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to manage multiple priorities simultaneously.

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