Document Control Officer

3 weeks ago

Pune, India Philips Full time

**Job Title**: Document Control Officer

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**
- Ensures latest revision level documents & records are uploaded to SharePoint site(s).
- Timely distribution of latest revision level documents & records to all appropriate users and ensures that obsolete documentation is removed from distribution / publication.
- Performs support functions such as printing and scanning.
- Issues document numbers and maintains document registers.
- Ensures proper document classification, sorting, filing and proper archiving.
- Reviews correct formatting and completeness of documentation and prepares document transmittals.
- Developing professional expertise, knowledgeable in company policies and procedures.
- Knowledge of Quality Management Systems and business processes.
- Basic knowledge of company products and services.
- CAPA Facilitator Support the intake of CAPA Requests from feeder processes, working with Initiators to refine problem descriptions to present to the CRB and/or CRB Chair for timely, clear and efficient approval per process.
- Support CRB Process
- may be called upon to present CAPA System Health metrics, prepare presentation decks and/or keep minutes for CRB reviews.
- Participates in CAPA Team meetings to give advice on tools / approaches to take to address deliverables of CAPA, helps team keep awareness of interfaces with other processes / interfaces and customer and / or auditor viewpoint.
- Review of CAPA execution / record - assure CAPA quality standards are met for execution and documentation before the CAPA may proceed to the next key step.
- Ensure CAPA records meet good documentation practices, are kept up to date, able to do well understood / stand alone for future reviews by 3rd parties.
- Practice to support continuous improvements efforts in the CAPA process may be called upon to gather inputs and / or present to support management review, audits, CAPA daily management and CRB meetings.
- Able to work with different levels of management in the organization and complete tasks with mínimal supervision.
- Identifies and addresses areas of concern or escalates as necessary.
- Actively involved in addressing issues, meeting schedules, and resolving problems.
- Reports to Document Control Lead/Manager or PQMS leadership.

**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**
- Any Engineering Degree with minimum 3 years of relevant experience.
- 2 years of Business or Administrative certificate preferred.
- MS Office skills, document control process understanding.
- Participation on teams.
- Awareness of FDA regulations and Quality Management Systems.
- Ability to operate efficiently and effectively in a fast-paced environment.
- Effective verbal and written communications.
- Has/will satisfactorily complete(d) the CAPA Facilitator Role Training Technical degree or equivalent background Understanding of CAPA process and key requirements.
- Quality System Audit skills / background / knowledge Practical knowledge of standards and regulations pertaining to the relevant QMS. (i.e: medical device industry. This includes but is not limited to 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), EU Medical Device Regulation (2017/745) Investigation.
- Problem Solving skills Strong statistical and analytical abilities including a sampling plan development.
- Strong organizational, writing/technical writing, GDP, (including clear logic and quality & regulatory compliance documentation approaches), verbal, and interpersonal skills Demonstrates Philips Behaviors.
- Basic Track-wise QCM Navigation Skills.
- Knowledge and experience in key QMS disciplines (e.g., production a

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