Patricia Tolmos Rodríguez-Piñero
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Patricia Tolmos Rodríguez-Piñero Email & Phone Number

Quality System Consultant, Lean 6 Sigma Master Black Belt, MSD, Medical Device, Combination Product, IVD, Risk Management, ISO/EU MDR/FDA/MDSAP/ Lead Auditor, QMS, Validation, PRRC. GMP, GCP. GDP. GLP, Validation, QA/QC at Thermo Fisher Scientific
Location: London, England, United Kingdom 12 work roles 3 schools
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Quality System Consultant, Lean 6 Sigma Master Black Belt, MSD, Medical Device, Combination Product, IVD, Risk Management, ISO/EU MDR/FDA/MDSAP/ Lead Auditor, QMS, Validation, PRRC. GMP, GCP. GDP. GLP, Validation, QA/QC
Location
London, England, United Kingdom
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Patricia Tolmos Rodríguez-Piñero is listed as Quality System Consultant, Lean 6 Sigma Master Black Belt, MSD, Medical Device, Combination Product, IVD, Risk Management, ISO/EU MDR/FDA/MDSAP/ Lead Auditor, QMS, Validation, PRRC. GMP, GCP. GDP. GLP, Validation, QA/QC at Thermo Fisher Scientific, a company with 53105 employees, based in London, England, United Kingdom. AeroLeads shows a matched LinkedIn profile for Patricia Tolmos Rodríguez-Piñero.

Patricia Tolmos Rodríguez-Piñero previously worked as QA Engineer at Thermo Fisher Scientific and Director at Pt Consultant Ltd. Patricia Tolmos Rodríguez-Piñero holds Msc, Advance Synthesis Organic Chemistry from Uk Open University.

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Thermo Fisher Scientific

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About Patricia Tolmos Rodríguez-Piñero

As a Quality Systems Consultant, I leverage my 20+ years of experience in QMS and Q&R Training Management to provide proven, trusted, and cost-effective solutions to clients in the global medical device industry. I have a Lean 6 Sigma Master Black Belt certification and a strong background in chemistry and biotechnology, which enable me to design, implement and maintain QMS, and to deliver high-quality training courses that comply with regulatory standards and best practices.I have successfully led and supported internal and external audits, remediation projects, root cause analysis, and continuous improvement initiatives for various medical devices, vaccines, and biopharmaceutical/pharmaceutical products. I am passionate about helping clients navigate complex regulatory pathways, reduce business risk and time-to-market, and maximize their potential for success. I am also fluent in English and Spanish, Dutch (A1), French (A1) which allows me to communicate effectively with diverse stakeholders and audiences.

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Thermo Fisher Scientific
Thermo Fisher Scientific
Quality System Consultant, Lean 6 Sigma Master Black Belt, MSD, Medical Device, Combination Product, IVD, Risk Management, ISO/EU MDR/FDA/MDSAP/ Lead Auditor, QMS, Validation, PRRC. GMP, GCP. GDP. GLP, Validation, QA/QC
waltham, massachusetts, united states
Employees
53105
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12 roles

Patricia Tolmos Rodríguez-Piñero work experience

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Director

Current
Pt Consultant Ltd

United Kingdom

Offer consultancy services for medical devices as well as pharmaceuticals and Biotech, as well as have a wide range of training available from Risk Management to EU MDR/IVDR and GxP courses.I can provide support activities such as:EU MDR & IVDR transitionAuditing servicesRemediating audit findingsDevice development and CE markingQMS requirementsTechnical.

Jan 2024 - Present

Quality And Regulatory System Consultant

Current
Freelance
Nov 2023 - Present

Quality Systems Consultant

MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. With decades of combined experience in the global medical device industry, we are uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.

Jul 2022 - Sep 2023

Global Biopharma Qara Training Manager

United Kingdom

May 2020 - Jul 2022

Qms And Q &R Training Manager

Eindhoven Area, Netherlands

Sep 2017 - Sep 2020

Quality Manager 1

Smith And Nephew Curacao N.V.

Curacao

  • Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report
  • GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting
  • Performing estimations for Validation and Testing activities
  • Leading and managing testing and validation activities in synchronization with project scope, schedule and objective
  • Daily/Weekly status reporting. Risk Management… Show more
  • Daily/Weekly status reporting. Risk Management & Timely Communication
Jan 2016 - May 2017

Qa Validation And Qc Manager

Octoplus
Oct 2014 - Jan 2016

Senior Scientific

Octoplus

Leiden

Oct 2013 - Oct 2014

Quality Compliance Manager

Crucell
  • To manage and develop the Quality Assurance function to ensure that all activities are carried out in compliance with current Good Manufacturing Practice and that the companies ISO 9001:2008, BRC and HACCP.
  • To be responsible for the QMS system.
  • To implement new systems such as Trackwise, LIMs, Compliance Wire, Everyangle, Eflow, PQMS, EDGE.
  • To operate as a key member of the technical team driving continual quality improvements across the… Show more To manage and develop the Quality Assurance function to ensure that all activities are carried out in.
  • To operate as a key member of the technical team driving continual quality improvements across the function.
  • Manage the customer complaints, deviations, change control and CAPA systems.
Nov 2012 - Jun 2013

Quality Compliance Head Of Department In R&D

Assist in implementing and maintaining the quality programs for the QA department including but not limited to, document control, supplier qualification, Technical Agreement implementation and internal/external audit program. * Review and approval of R&D deviations, OOS, CAPAs, audit comments and other related quality records and providing QA input into.

Oct 2011 - Nov 2012

Senior Technitian In Validation

  • To plan and prioritise the day to day workload of the section to ensure efficient use of resource and timely validations.
  • To provide technical support for ad-hoc tasks and new projects, both commercial and PDS.
  • To negotiate with production staff for access to equipment and agree dates for access.
  • Assist the investigation of problems and provide support to the business in resolving quality issues
  • To ensure compliance to the section and site’s procedures.
  • To ensure… Show more
Jul 2006 - Oct 2011
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Colleagues at Thermo Fisher Scientific

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3 education records

Patricia Tolmos Rodríguez-Piñero education

Msc, Advance Synthesis Organic Chemistry

Uk Open University

Activities and Societies: Membership of Royal Society of Chemistry

Bachelor Of Science (Bsc), Analytical Chemistry, A

Uned
FAQ

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What company does Patricia Tolmos Rodríguez-Piñero work for?

Patricia Tolmos Rodríguez-Piñero works for Thermo Fisher Scientific.

What is Patricia Tolmos Rodríguez-Piñero's role at Thermo Fisher Scientific?

Patricia Tolmos Rodríguez-Piñero is listed as Quality System Consultant, Lean 6 Sigma Master Black Belt, MSD, Medical Device, Combination Product, IVD, Risk Management, ISO/EU MDR/FDA/MDSAP/ Lead Auditor, QMS, Validation, PRRC. GMP, GCP. GDP. GLP, Validation, QA/QC at Thermo Fisher Scientific.

Where is Patricia Tolmos Rodríguez-Piñero based?

Patricia Tolmos Rodríguez-Piñero is based in London, England, United Kingdom while working with Thermo Fisher Scientific.

What companies has Patricia Tolmos Rodríguez-Piñero worked for?

Patricia Tolmos Rodríguez-Piñero has worked for Thermo Fisher Scientific, Pt Consultant Ltd, Freelance, Medicept Inc., and Cytiva.

Who are Patricia Tolmos Rodríguez-Piñero's colleagues at Thermo Fisher Scientific?

Patricia Tolmos Rodríguez-Piñero's colleagues at Thermo Fisher Scientific include Nico Gruber, Janice Clarke, Syed Yunus, Ranjit Choubey, and Thiru Thamo.

How can I contact Patricia Tolmos Rodríguez-Piñero?

You can use AeroLeads to view verified contact signals for Patricia Tolmos Rodríguez-Piñero at Thermo Fisher Scientific, including work email, phone, and LinkedIn data when available.

What schools did Patricia Tolmos Rodríguez-Piñero attend?

Patricia Tolmos Rodríguez-Piñero holds Msc, Advance Synthesis Organic Chemistry from Uk Open University.

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