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Stark Pharma Solutions Inc Linkedin · Posted 2mo ago

GMP QC Systems Consultant

Frankford

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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. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

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: [email protected]

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com

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