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A Client Bridges Quality Gaps with statementworX Project Delivery.

10/28/2024

The challenge

Seamless Entry into the Regulated Pharmaceutical Market. 

A leading specialty chemical company was striving to expand into the pharmaceutical market, a sector known for its stringent regulatory environment and rigorous quality standards. To successfully make this transition, the company needed a comprehensive overhaul of its Quality Management System (QMS) to align with Good Manufacturing Practices (GMP). This required identifying and addressing critical quality gaps to ensure compliance and the ability to operate within a highly regulated industry. 

 

The solution

An Expert Team Assembled to Address Quality Gaps.

Kelly Science & Clinical utilized their statementworX Project Delivery model, quickly assembling a team of experts to address quality gaps, including: 

  • Quality Associate: Overhauled documentation to meet GMP standards by drafting SOPs, conducting internal audits, administering training, managing mock recalls and customer complaints. 
  • Validation Engineer: Focused on validating essential processes and equipment, creating risk assessment protocols, and performing thorough process validation studies. 
  • Analytical Chemist: Specialized in method validation for advanced techniques like FTIR and GC-FID, establishing precise data collection and reporting guidelines, and ensuring reliable laboratory practices. 

The value

Compliance, Operational Efficiency, and Market Readiness. 

By deploying the statementworX SOW-based service model, Kelly delivered: 

  • Expertise and Precision: Identified and bridged quality gaps, ensuring regulatory compliance. 
  • Enhanced Compliance: Achieved GMP standards, paving the way for pharmaceutical market entry. 
  • Operational Excellence: Implemented robust validated processes, documentation, and training systems. 
  • Client Confidence and Satisfaction: Ensured peace of mind with comprehensive quality solutions and expert support. 

Kelly Science & Clinical ensured a seamless transition for the specialty chemical company into the pharmaceutical market, transforming their quality landscape. 

See Kelly Science & Clinical for quality assurance staffing solutions from a leading quality control staffing agency. 

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