Qms Administrator

Year    Pune, Maharashtra, India

Job Description

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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 its not just what we do, its 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. Its 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. Thats 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, youll 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, youll 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 peoples 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 collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyones in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnt office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips?
Working at Philips is more than a job. Its a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. #LI-PHILIN
  • Health insurance

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Job Detail

  • Job Id
    JD3029183
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Pune, Maharashtra, India
  • Education
    Not mentioned
  • Experience
    Year