Packaging Documentation Specialist

2 days ago

Bengaluru, Karnataka, India beBeeLabeling Full time ₹ 9,00,000 - ₹ 12,00,000

Job Summary

Manage labeling databases, track issues, and maintain QSR (Quality Systems Records) and related materials for the creation/revision and control of customer labeling.

Develop, implement, and maintain effective document control systems to ensure compliance with regulatory requirements.

Collaborate with cross-functional teams to identify areas for improvement and execute continuous improvement initiatives.

Expedite change request consideration and approval processes by coordinating reviews by stakeholders and managing approvers for timely response.

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.

Key Responsibilities:

  • Document Management: Manage documents to support Labeling Development in compliance with ISO, cGMP, and FDA guidelines.
  • Change Control: Complete Engineering Change Requests for Global Labeling & Packaging.
  • Review Process: Initiate the collaborative review process and assist document users with inquiries and research.
  • Documentation Tracking: Track documentation through the entire development process while adhering to strict timelines.
  • Communication: Effectively communicate activity status, issues, and mitigation plans with key stakeholders.

Required Skills and Qualifications

Knowledge of Microsoft Office's suite of products and 3+ years of hands-on experience in medical device document controller roles.

Strong self-motivation, ability to work independently, and strong follow-up, organization, and prioritization skills.

Excellent communication skills, both written and verbal. Strong interpersonal skills to manage multiple projects at once and establish effective working relationships with coworkers, managers, and clients.

Benefits

This position offers a unique opportunity to work with a dynamic team and contribute to the success of our organization.

We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan and paid time off.

Others

If you are a motivated and detail-oriented individual with a passion for document management and process improvement, we encourage you to apply.

We thank all applicants for their interest; however, only those selected for an interview will be contacted.

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