Location
India | India
Job description
Job Description
Job TitleQMS ManagerJob Description
Job title:
One sentence description of role
Your role:
- Ensures compliant and effective QMS's are maintained in scope.
- Accountable for the transformation of all current QMS's parts in scope towards the single PQMS structure.
- Accountable to manage and harmonize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope.
- Manages (local) Q&R processes and ensures (local) process ownership for all activities under the PQMS governance in scope.
- Ensures Q&R requirements are effective in all processes in scope.
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.
- Administers a compliant and effective QMS for the activities in scope.
- Enables the transition/deployment of the PQMS and manages its deployment.
- Ensures proper audit planning and schedule meets the requirements of internal policies and external regulations.
- Locally manages plans for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS.
- Administers and contributes to the management of any local QMS documents in line with the evolution of the PEQS and the PQMS.
- Supports training and training administration as per the QMS and contributes to training content for local QMS documents as necessary.
- Contributes to the availability of metrics/KPI data to measure training effectiveness, PQMS deployment and QMS Compliance.
- Works on issues where analysis of situation or data requires review of relevant factors.
- Exercise judgement within defined procedures and policies to determine appropriate action.
You're the right fit if: (4 x bullets max)
- Minimum 7+ years of similar work experience.
- Experience working in disciplined regulated industry and in applying automated technology
- Experience with business application implementation projects, including experience as an active contributor on projects and scheduled deliverables.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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