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A growing pharmaceutical manufacturing company in Tripoli, Libya is seeking an experienced American pharmaceutical manufacturing consultant with expertise in solid oral dosage forms (tablets, capsules, and powders) to provide on-site consulting services for approximately one week. The consultant will evaluate current manufacturing operations, provide technical guidance, and help establish best practices for producing high-quality pharmaceutical products in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and international pharmaceutical standards.
Responsibilities
* Assess compliance with FDA regulations, cGMP requirements, and international pharmaceutical manufacturing standards.
* Review manufacturing processes for tablets, capsules, powders, and related solid dosage products.
* Evaluate quality systems, documentation practices, batch records, and SOPs to ensure alignment with FDA expectations and cGMP requirements.
* Provide recommendations for regulatory readiness, inspection preparedness, and operational excellence.
* Train production, quality assurance, and quality control teams on FDA regulations, cGMP compliance, data integrity, and pharmaceutical manufacturing best practices.
Required Qualifications
* Minimum 10 years of pharmaceutical manufacturing experience.
* Extensive knowledge of FDA regulations (21 CFR Parts 210 and 211) and current Good Manufacturing Practices (cGMP).
* Demonstrated expertise in the manufacturing of solid oral dosage forms, including tablets, capsules, and powder formulations.
* Experience preparing for, supporting, or responding to FDA inspections and audits.
* Strong understanding of pharmaceutical quality systems, validation programs, documentation controls, and regulatory compliance.
Candidate Profile
The ideal candidate is a seasoned pharmaceutical manufacturing professional with substantial experience in solid oral dosage manufacturing, who possesses deep knowledge of FDA regulations, cGMP compliance, quality systems, validation, and pharmaceutical operations. The consultant will provide practical guidance to help establish and strengthen a pharmaceutical manufacturing facility that meets international quality and regulatory standards.