Key Facts

Remote From:

Freelance

English

Hard Skills

Computer System Validation Data Integrity Title 47 CFR Part 15 Educational Assessment End-User License Agreement Standard Operating Procedure Commissioning Qualification Validation (CQV) Corrective And Preventive Action (CAPA) Quality Assessment Due Diligence +7 more

Other Skills

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Investigation
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Training And Development
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Consulting
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Virtual Teams

Roles & Responsibilities

Experience as a Life Sciences consultant in cGMP pharmaceutical or biotech environments
Strong knowledge of compliance disciplines including CFR Part 11, CSV, and Data Integrity/Governance
Experience with Commissioning & Qualification (C&Q), Quality System Implementation, and SOP/Policy Development
Experience with FDA remediation, Investigation/Deviation (CAPA), audits/assessments, and mock FDA inspections

Requirements:

Provide consulting support across compliance programs including training, cGxP activities, and SOP/policy development
Perform or oversee CSV, CFR Part 11, and Data Integrity/Governance activities, audits, and assessments
Lead commissioning & qualification activities and quality system implementations
Support FDA remediation, investigations and deviations (CAPA), mock inspections, due diligence, and license application assistance

MEDVACON LIFE SCIENCES, LLC

Pharmaceuticals

About MEDVACON LIFE SCIENCES, LLC

MEDVACON is a renowned company recognized globally for providing tailored FDA Quality Compliance and Technical Consulting Services. With an unwavering commitment, MEDVACON partners with Life Sciences Companies to achieve optimal solutions while effectively managing compliance-related expenditures. MEDVACON’s extensive array of services reflects our dedication to client satisfaction. Our proficiency encompasses Validation, Qualification, Quality Systems, IT Computer System Validation/Software Quality Assurance (CSV/SQA), FDA Audit Preparation, Response and Remediation Services, as well as Training, Tech Transfers, and Project Management. We look forward to partnering and working with you and your organization! MEDVACON, Elevating Excellence

Company type: SME

Industry: Pharmaceuticals

Founded: 2018

Company size: 51 - 200

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Job description

We are looking to connect with experienced consultants open to working now or on future assignments in cGMP pharmaceutical or biotech setting on assignments involving:

Compliance and Training
CSV & CFR Part 11
Data Integrity / Governance
Commissioning and Qualification
Quality System Implementation
Compliance ~ cGxP Consulting
Investigation and Deviation – CAPA
FDA Remediation
Audits and Assessments
Mock FDA Inspections
SOP / Policy Development
M&A Due Diligence
License Application Support

While we are headquartered in Sparta, NJ, we continually have a high number of consulting and contracting assignments on 1099 across the US.

A member of our Talent team will be in touch to discuss your application in more detail. In the meantime, check out our website: Home — Medvacon Life Sciences LLC

Quality Grind Podcast: Quality Grind Podcast — Medvacon Life Sciences LLC

Blog Series: Blog — Medvacon Life Sciences LLC

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.

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