Company

DocumentationControl

Bengaluru, Karnataka, India
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Documentation Control. Skills: documentation control, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Support documentation and training activities within the Global Management System (GMS) and legacy systems. Maintain document control, retention, and change control processes and associated tools”

What You'll Achieve.

Prepare KPIs, reports, dashboards, and presentations related to documentation control and compliance processes; Ensure activities are completed within defined timelines

What They're Looking For.

Must Have

Bachelor’s degree in Scientific, Medical, Technical, or related field, Minimum 5 years of overall work experience, Minimum 3 years of experience in Medical Devices or Pharmaceutical industry, Knowledge of applicable standards and regulations such as ISO 13485, ISO 9001, ISO 14001, GxP, and MDSAP, documentation, compliance, coordination, and communication skills

Nice to Have

Experience with electronic document management systems and integrated quality management tools preferred

What You'll Do.

Support documentation and training activities within the Global Management System (GMS) and legacy systems

Maintain document control

and change control processes and associated tools

Support electronic document management systems such as QDOK and Windchill including user management

Conduct periodic review of controlled documents and support document lifecycle management activities

Participate in continuous improvement initiatives related to workflows

and harmonization of legacy systems

Perform document change requests

formal document reviews

and controlled document updates

Support translation and implementation activities for controlled documents

Prepare Local Implementation Requests (LIR) and related documentation activities

Support regulatory training processes and associated systems/tools

and presentations related to documentation control and compliance processes

Maintain electronic collaboration and document storage platforms such as MS Teams and SharePoint

Ensure activities are completed within defined timelines and maintain training records/evidence

How You'll Work.

Communication Scope

communication skills

Full Job Description

**Key Responsibilities:** • Support documentation and training activities within the Global Management System (GMS) and legacy systems. • Maintain document control, retention, and change control processes and associated tools. • Support electronic document management systems such as QDOK and Windchill including user management, troubleshooting, and training. • Conduct periodic review of controlled documents and support document lifecycle management activities. • Participate in continuous improvement initiatives related to workflows, eDMS tools, and harmonization of legacy systems. • Perform document change requests, formal document reviews, and controlled document updates. • Support translation and implementation activities for controlled documents. • Prepare Local Implementation Requests (LIR) and related documentation activities. • Support regulatory training processes and associated systems/tools. • Prepare KPIs, reports, dashboards, and presentations related to documentation control and compliance processes. • Maintain electronic collaboration and document storage platforms such as MS Teams and SharePoint. • Ensure activities are completed within defined timelines and maintain training records/evidence. **Qualifications:** • Bachelor’s degree in Scientific, Medical, Technical, or related field. • Minimum 5 years of overall work experience. • Minimum 3 years of experience in Medical Devices or Pharmaceutical industry. • Knowledge of applicable standards and regulations such as ISO 13485, ISO 9001, ISO 14001, GxP, and MDSAP. • Experience with electronic document management systems and integrated quality management tools preferred. • Strong documentation, compliance, coordination, and communication skills.

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