Nikhil Jalali

Operations Associate

Bengaluru, Karnataka, India17 yrs 4 mos experience
Most Likely To SwitchHighly Stable

Key Highlights

  • 17+ years of experience in quality management.
  • Expertise in regulatory compliance for healthcare.
  • Proven track record in CAPA and audit management.
Stackforce AI infers this person is a Quality Management expert in the Healthcare industry.

Contact

Skills

Core Skills

Quality Management SystemsCapaChange ManagementSoftware Validation

Other Skills

Medical DevicesRequirements traceabilityValidationSOPComputer System ValidationSDLCV&V21 CFR Part 11AutomationHVACQuality SystemFDAPLC ValidationHVAC system validationWater system validation

About

Nikhil Jalali emerges as a seasoned Quality leader with a comprehensive skill set and a keen eye for detail, making him a valuable contributor to the advancement of quality management practices in the healthcare domain. His extensive experience of 17 plus years spanning across various industries, including pharmaceuticals, medical devices, and consulting, demonstrates a deep understanding of the intricacies of these sectors. His expertise in Quality Management Systems, IT change management and computer system validation is particularly noteworthy given the critical nature of these areas in ensuring regulatory compliance and operational efficiency. His tenure at renowned organizations like Jubilant Life Sciences, Rockwell Automation India Pvt. Ltd, Cognizant and Philips underscore his credibility and proficiency in navigating complex regulatory landscapes such as FDA regulations, ISO-13485, 21 CFR-820 and GAMP guidelines. His familiarity with Software Validation, CAPA and Audit Management, QMS implementation, IT change management, Procedures and work instructions and different software development methodologies like Waterfall and Agile further enhances his versatility in addressing diverse challenges within the industry. As a Senior IT Quality Manager at Philips IT, Nikhil plays a pivotal role in driving process excellence and effective QMS compliance within the organization. His proactive approach to strengthening processes and making robust QMS aligns well with Philips commitment to delivering high-quality products and services in the healthcare sector. His effective communication and presentation skills undoubtedly facilitate smooth collaboration with stakeholders, ensuring a clear understanding of objectives and expectations.

Experience

17 yrs 4 mos
Total Experience
3 yrs 5 mos
Average Tenure
8 yrs 3 mos
Current Experience

Philips

3 roles

Senior Manager- IT Quality

Promoted

Apr 2024Present · 2 yrs 2 mos

  • Simplifying IT and Quality processes to increase Productivity.
  • Responsible for robust QMS by ensuring structured framework of policies, processes, and procedures are designed and deployed within the QMS to ensure that medical device consistently meet safety, quality, and regulatory requirements throughout their entire lifecycle.
  • CAPA management and Audit Management.
Medical DevicesCAPAQuality Management Systems

IT Quality Manager | Business Process Expert

Oct 2021Apr 2024 · 2 yrs 6 mos

  • BPE and for Philips IT change management process.
  • CAPA Management and Audit Management.
  • Training compliance and process adherence.
CAPAChange Management

Software Validation Lead

Mar 2018Oct 2021 · 3 yrs 7 mos

  • Enabling regulatory compliance for Philips healthcare IT applications.
  • Responsible for authoring of validation plan and validation summary reports.
  • Responsible for authoring of test protocols.
  • Requirements traceability matrix compliance.
CAPASoftware Validation

Datwyler it services

Manager-Quality and Regulatory

Dec 2017Mar 2018 · 3 mos · Pune, Maharashtra, India

  • Managing IT regulatory compliance for GxP applications.
  • QMS implementation.
  • CAPA and Audit Management.
  • Training Management.
CAPAQuality Management Systems

Cognizant

Consultant-CSV

Feb 2015Dec 2017 · 2 yrs 10 mos

  • Regulatory and Compliance for Mylan Global.
  • Validation of global applications.
  • Authoring of Validation Plan and Validation Summary Reports.
  • Maintaining requirements traceability matrix.

Rockwell automation

Consultant-Computer System Validation

Oct 2012Feb 2015 · 2 yrs 4 mos · Noida Area, India

  • Computer System Validation, User Requirement Specification,Validation Planning, Quality Project Plan, Test Plan, Design Specifications, Factory Acceptance Testing, IQ, OQ.

Jubilant life sciences ltd

Senior Engineer (validation)

Sep 2009Oct 2012 · 3 yrs 1 mo · Roorkee

  • Validation Master Plan, HVAC validation, Water Validation, Equipment Qualification, GMP, SOP drafting.

Uttam galva steels ltd.

Trainee Engineer

Aug 2008Jun 2009 · 10 mos

Education

Savitribai Phule Pune University

BE — Mechanical

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