Jump Start Your Hiring
Click to Proceed Today! 

Retained Search Program

Internal/External Audits: Conduct GMP, GLP, and GCP audits.

Post-Market Surveillance: Monitor product safety and performance in the market.

Inspection Support: Provide guidance during regulatory inspections.

Platform Expertise: Configure and support Delta V, Rockwell, Siemens, and PLC-based systems.

Integration: Connect automation systems with MES, LIMS, and ERP platforms.

Equipment Qualification: Lead FAT/SAT for fill-finish lines, packaging, and injector assembly.

Clean Room & Facility Design: Plan, build, and qualify GMP-compliant manufacturing and laboratory spaces.

Project Oversight: Manage timelines, budgets, and contractor coordination.

Analytical Testing: Perform chemical, biological, and microbiological assays.

Compliance Assurance: Validate software and automated systems to meet 21 CFR Part 11 and other regulatory standards.

Sterilization, Packaging, Cleaning Validation: Develop and execute validation protocols for critical manufacturing processes.

Document Management: Oversee creation, revision, approval, and archiving of controlled documents.

Validation: Develop and execute validation protocols for freeze-drying processes.

Batch Record Review: Ensure all production and testing documentation meets regulatory standards.

Process Development: Optimize production methods and scale-up processes.

System Design: Engineer new or upgrade existing mechanical, electrical, and software systems for manufacturing and laboratory environments.

Test Protocol Development: Author and execute test plans for equipment and systems.

Production Leadership: Oversee daily manufacturing operations, resource planning, and KPI tracking.

GAP Analysis: Identify deficiencies in existing quality systems relative to FDA, EMA, and global regulatory standards.

Design & Optimization: Develop and refine manufacturing and laboratory processes for efficiency, scalability, and compliance.

Implementation: Deploy and configure Manufacturing Execution Systems (MES) to manage production workflows.