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PQMS E2E PIL Compliance Expert

10.00 to 15.00 Years   Bangalore   23 Feb, 2021
Philips
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

nullIn this role, you have the opportunity toProvide guidance and drive standardization of business processes alignment with software systems used by multiple Philips Business Groups. This is done through education and partnering with stakeholders across business functions including IT, Business, and Quality & Regulatory.You are responsible forFor each deployable Global Aris publication:

  • Coaches BPOs/BPEs & PIL teams on acceptable linkages between PEPF processes and PIL Applications.
  • Coaches BPOs and E2E Project teams on the QMS elements in SIM and participates in SIM SG reviews/approvals.
  • Ensures PEPF/PIL alignment is correct.
  • Ensures PEPF process control requirements are acceptably embedded in related PIL solutions.
  • Reviews and approves PIL validation deliverables for consistency against PEPF process definitions.
  • Participates directly as the Q&R process automation expert in PEPF programs.
  • Tracks/reports KPIs on each Global Aris publication L3 to be deployed, the related PIL solution version and it s level of compatibility.
You are a part ofAn established and structured organization, working for Philips E2E Q&R PQMS team. Together with your colleagues, you will lead by example and drive quality and compliance throughout all of Philips s business processes. Your responsibility is to provide guidance and drive standardization of business processes alignment with software systems used by multiple Philips Business Groups. In this role, you will work with Philips E2E BPO / BPE s & PIL teams, as well as any other stakeholders to ensure PEPF/PIL alignment, effectiveness, and compliance to the applicable regulations.To succeed in this role, you should have the following skills and experience
  • Education level of Bachelor s degree, preferably in a scientific discipline (technical or engineering or/and IT related field(s)).
  • Minimum of 10-15 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting functional disciplines within a global medical device (Pharma) industry.
  • In-depth knowledge of Quality management systems. Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation etc. other worldwide Quality System Regulations and guidance documents: GPSV / AAMI TIR36.
  • Good analytical skills and process improvement capabilities with the ability to resolve issues of diverse scope by following processes and operational policies in selecting methods and techniques for obtaining solutions.
  • Excellent communication skills, being proactive, high engagement, motivation and flexibility - a driver of change
In return, we offer youDescribe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.Why should you join Philips Working at Philips is more than a job. It s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.To find out more about what it s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.,

Keyskills :
process automationquality engineeringmedical device directiveprocess improvementiso 14971iso 13485quality managementquality systemproject teams21 cfranalytical skillsquality systems quality assurance

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