Quality And Regulatory Affairs Principal Consultant
Sashei Pharma Consulting
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Sandra Rincon Email & Phone Number
Quality and Regulatory Affairs Principal Consultant
at
Sashei Pharma Consulting
1 work email found
@compliance-insight.com
1 phone found area 513
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Sashei Pharma Consulting
Role
Quality and Regulatory Affairs Principal Consultant
Location
Pompano Beach, Florida, United States
Who is Sandra Rincon? Overview
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Quick answer
Sandra Rincon is listed as Quality and Regulatory Affairs Principal Consultant at Sashei Pharma Consulting, based in Pompano Beach, Florida, United States. AeroLeads shows a work email signal at compliance-insight.com, phone signal with area code 513, and a matched LinkedIn profile for Sandra Rincon.
Sandra Rincon previously worked as Quality and Regulatory Affairs Principal Consultant at Sashei Pharma Consulting Llc and Regulatory Compliance SME at Validant. Sandra Rincon holds Master'S Degree, Regulatory Affairs For Drugs, Biologics And Medical Devices from Northeastern University.
Company email context
Email format at Sashei Pharma Consulting
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{first}@compliance-insight.com
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Profile bio
About Sandra Rincon
A pharmaceutical professional with over twenty years of experience in Quality Operations, and Regulatory Affairs, including method development and validation, cGMP, FDA, EP, DEA and ANVISA compliance, solid dosage manufacturing, including development processes. Experience in the implementation and validation of automated testing coupled with Empower software. Experience in the elaboration of the CMC module 3.An accomplished professional with demonstrated success in all aspects of practice. A strong team player with high communication skills, practical knowledge of trend analyses, forecasting, laboratory technical work, handling of hazardous materials, and effective inventory control and regulatory compliance.• Focused on organizational missions and philosophy while positively impacting bottom line and performance. Success oriented Professional with managerial experience, possessing an extensive knowledge of the laboratory, procedures and policies necessary to consistently produce a safe, superior product.• Proven People Management skills utilized in simultaneously directing the activities of direct reports while consistently delivering projects on time and on budget. An outstanding record of greatly improving profitability and productivity while more effectively aligning service with all levels within the organization.
Listed skills include Gmp, Validation, Fda, Change Control, and 40 others.
Current workplace
Sandra Rincon's current company
Company context helps verify the profile and gives searchers a useful next step.
Sashei Pharma Consulting
11 roles · 29 years
Sandra Rincon work experience
A career timeline built from the work history available for this profile.
Quality And Regulatory Affairs Principal Consultant
Current
Sashei Pharma Consulting Llc
Jul 2020 - Present
Regulatory Compliance Sme
Comprehensive assessment of the Customers' Quality system conducted and remediation plan elaborated and executed successfully, in order to comply with FDA regulations
Sep 2015 - Jun 2020
Qa/Ra Consultant
Sashei Pharma Consulting
Worked in reviewing and improving Quality Management Systems, based ICH Q10. Quality Quality Agreements, evaluation and follow up of CMOs and CROs (under cGXP) were performed.
Jul 2014 - Sep 2015
Regulatory Compliance Consultant
Independent Consultant
Review and evaluate CMC post-approval manufacturing changes for NDA and ANDA submissions in order to document them in the annual product report.Work in the elaboration of CMCs for INDs phase II and III.
2013 - 2014
~1 yr
Quality Auditor Consultant
Independent Consultant
-Working in a company specialized in parenteral drugs and infusion technologies, providing mentoring for the Quality Control laboratory, in areas as technical support, investigations, laboratory events, revision of the controlled document forms training, as well as enforcing compliance following company and FDA policies.Conducting GLP audit assessment.
2012 - 2013
~1 yr
Compliance Auditor
Independent Consultant
Working in a mock auditing, to comply with FDA, 21 CFR Parts 210/211, part 820 and ANVISA requirements
2012 - 2012
Quality Auditor
An evaluation of the retrospective Out of Specification was provided, implementing the corresponding corrections, opening CAPAs and change control when it's necessary, A training system was implemented and a complete by the analyst and the stability program was restructured in order to be in compliance with COFEPRIS and FDA regulations.
Feb 2012 - 2013
Quality Remediation Consultant
Identification and Impact assessment of the Change Control documentation.Elaborating process maps for raw material incoming sampling, inspection, testing and documentation. GAP assessment reports specifying deficiencies and deviations from the FDA and remediation plan implementation including revision of existing procedures, specifications and development.
2011 - 2012
~1 yr
Technical Sevices Scientist Sr
Execute, write and evaluate complex protocols and reports, for method transfer, method validations method verifications for finished products and raw material. Create and review Standard Test Methods, Specifications, and Procedures in compliance with FDA & DEA regulations.Vast experience performing internal audits, evaluating instrumentation IQ, OQ and PQ.
2001 - 2011
~10 yrs
Logistic Manager
Lakor Pharmaceutical
-Managing logistic processes for solid dosage products such as Propafenone, Metoprolol, Sodium Alendronate, etc. Started with the purchase of raw materials and equipment, preparation of protocols and reports, validation processes, following the production at Sanofi-Syntelabo (outsourcing company) of packaging, labeling and delivery of the final.
1997 - 2000
~3 yrs
2 education records
Sandra Rincon education
Master'S Degree, Regulatory Affairs For Drugs, Biologics And Medical Devices
Northeastern University
Pharmaceutical Sciences (Bs)/ Bachelor Of Pharmacy (Bpharm)
Universidad De Antioiquia
FAQ
Frequently asked questions about Sandra Rincon
Quick answers generated from the profile data available on this page.
What company does Sandra Rincon work for?
Sandra Rincon works for Sashei Pharma Consulting.
What is Sandra Rincon's role at Sashei Pharma Consulting?
Sandra Rincon is listed as Quality and Regulatory Affairs Principal Consultant at Sashei Pharma Consulting.
What is Sandra Rincon's email address?
AeroLeads has found 1 work email signal at @compliance-insight.com for Sandra Rincon at Sashei Pharma Consulting.
What is Sandra Rincon's phone number?
AeroLeads has found 1 phone signal(s) with area code 513 for Sandra Rincon at Sashei Pharma Consulting.
Where is Sandra Rincon based?
Sandra Rincon is based in Pompano Beach, Florida, United States while working with Sashei Pharma Consulting.
What companies has Sandra Rincon worked for?
Sandra Rincon has worked for Sashei Pharma Consulting, Sashei Pharma Consulting Llc, Validant, Independent Consultant, and Compliance Architects.
How can I contact Sandra Rincon?
You can use AeroLeads to view verified contact signals for Sandra Rincon at Sashei Pharma Consulting, including work email, phone, and LinkedIn data when available.
What schools did Sandra Rincon attend?
Sandra Rincon holds Master'S Degree, Regulatory Affairs For Drugs, Biologics And Medical Devices from Northeastern University.
What skills is Sandra Rincon known for?
Sandra Rincon is listed with skills including Gmp, Validation, Fda, Change Control, Sop, Quality Control, Glp, and Pharmaceutical Industry.
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