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Qms Administrator

2 months ago

Pune, India Philips Full time

**Job Title**: QMS Administrator

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

**In this role, you have the opportunity to make life better**
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

**You are responsible for**
- Maintain, enforce and manages a compliant and effective QMS for the activities in scope as well as for effective and lean QMS structures and documents for Q&R processes.
- Supporting QMS manager to manage and harmonize all QMS management processes and ensure compliance to FDA, MDD/EU-MDR, ISO 13485 etc.
- Review and approve QMS documents and records, ensuring GDP compliance.
- Support QMS manager to manage the transition /deployment of the PQMS and manage its deployment.
- Collects and maintains documents & records of the latest revision level.
- Timely distribution of latest revision level documents & records to all appropriate users and ensures that obsolete documentation is removed from distribution / publication.
- Maintains the document management system an ensure fast retrieval of documents & records.
- Controls issuance of document numbers including maintenance of proper document registers.
- Ensures proper document classification, sorting, filing and proper archiving.
- Reviews correct formatting and completeness of documentation and prepares document transmittals.
- Administer learning assignments by using the standardized training administration processes.
- Create, manage and maintain standardized roles in the Learning Management System.
- Establish Document Control support to authors and process owners/SME in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records.
- Establish and manage proper document review processes.
- Ensures availability/publishing of controlled documents.
- Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business.
- Manage document and record control.
- Support internal and external Audits.

**You are a part of** A high performing quality organization who put customer first with high standard of patient safety, quality and integrity.

**To succeed in this role, you’ll need a customer-first attitude and the following**
- Bachelor's Degree in Engineering or equivalent with interest in process management or process improvement.
- 3 to 5 years related experience in change control and/or document control field.
- Advanced MS Office skills, document control process understanding.
- Experience in change control and or document control field.
- Procedural or Technical writing experience.
- Good communication - effective written and oral communication skills, organizational and project management skills.
- Be familiar with ISO 13485, ISO 9001, 21CRF 820.
- Ability to operate efficiently and effectively in a fast-paced environment.
- Knowledge and experience in key QMS disciplines (e.g. production and process quality control, design quality control, post market surveillance quality control).
- Intermediate user of Microsoft Excel, Word and Outlook.
- Customer service experience.
- Self-starter, motivated, action-oriented.
- Experience working in global corporate environment.
- Fluent English.

**In return, we offer you**

A challenging and dynamic assignment in an organization that continuously strives to develop its talent. You will contribute to our mission to improve people’s lives around the globe through meaningful innovation. We welcome you to a challenging, innovative environment with great opportunities for you to explore. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

**How we work at Philips**
Our newly-adopted hybrid work concept fuses flexibility with

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