GMP QC Systems Consultant

Stark Pharma Solutions Inc; Frankford (DE); On-site; USD 110,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc in Frankford, DE is seeking a GMP QC Systems Consultant for a 12+ month contract onsite. The ideal candidate will drive the implementation, integration, and validation of Quality Control laboratory systems in a regulated pharma setting.

The role requires 8+ years in GMP environments, hands-on CSV/CSA, GAMP5, IQ/OQ/PQ, and data migration. Collaboration with QA, IT, and laboratory teams is essential to ensure project success and regulatory compliance.

Qualifications

• 8+ years of experience in GMP-regulated environments (pharma/biotech).
• Experience implementing and validating QC laboratory systems.
• Strong CSV/CSA, GAMP5, IQ/OQ/PQ knowledge and risk-based validation approach.
• Cross-functional project coordination and data migration experience.

Responsibilities

• Lead implementation and integration of GMP QC laboratory systems.
• Coordinate configuration, data migration, deployment, and go-live activities.
• Manage project timelines, risks, budgets, and stakeholder communications.
• Support CSV/CSA activities including IQ/OQ/PQ execution and documentation.
• Perform risk assessments, testing, and validation per GAMP5 and GxP requirements.
• Collaborate with QA, IT, lab teams, vendors, and stakeholders for delivery.
• Ensure compliance with GxP and Data Integrity; prepare status reports.

Skills

GMP QC Systems

CSV/CSA

GxP validation

Project management

Stakeholder management

Communication

Risk assessment

Documentation

Education

Bachelor's degree in Life Sciences

Tools

LIMS

SDMS

Empower

LabX

QuantStudio

SoftMax Pro

Job description

Hi, My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on GMP QC Systems Consultant position right now.

Position:

GMP QC Systems Consultant

Location: Frankford, DE (100% Onsite)

Duration: 12+ Month Contract

Job Overview

We are seeking an experienced GMP QC Systems Consultant to support the implementation, integration, and validation of Quality Control laboratory systems in a regulated pharmaceutical environment. The ideal candidate will have strong expertise in GMP laboratory systems, Computer System Validation (CSV/CSA), and cross-functional project execution.

Key Responsibilities

• Lead implementation and integration of GMP QC laboratory systems.
• Coordinate system configuration, data migration, deployment, and go-live activities.
• Manage project timelines, risks, budgets, and stakeholder communications.
• Support Computer System Validation (CSV/CSA), including IQ/OQ/PQ execution and documentation.
• Perform risk assessments, testing, and validation activities in compliance with GAMP5 and GxP requirements.
• Collaborate with QA, IT, laboratory teams, vendors, and business stakeholders to ensure successful project delivery.
• Ensure compliance with GxP, Data Integrity, and internal quality standards.
• Prepare project status reports and support release readiness activities.

Required Qualifications

• 8+ years of experience in Pharmaceutical, Biotechnology, or other GMP-regulated environments.
• Strong experience implementing and validating QC/Laboratory systems.
• Hands-on knowledge of CSV, CSA, GAMP5, GxP, IQ/OQ/PQ, and risk-based validation.
• Experience with system integration, data migration, and cross-functional project coordination.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, LabX, QuantStudio, SoftMax Pro, or similar systems.
• Excellent communication, documentation, and stakeholder management skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: [e-mail]

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com