- 经验
- 10年以上经验
- 薪水
- —
- 职位空缺
- 1
- 发布
- 2周前
- 工作模式
- 在办公室
- 合格
- Experienced American pharmaceutical manufacturing professionals with strong expertise in solid oral dosage forms and regulatory compliance are invited to apply.
- 恢复
- 需要申请
职位描述
Overview
A pharmaceutical manufacturing company based in Tripoli, Libya is looking for a seasoned American consultant to support its solid oral dosage manufacturing operations on site for roughly one week. The assignment focuses on reviewing current practices, strengthening compliance, and setting up effective standards for producing high-quality medicines.
Engagement Focus
The consultant will examine existing manufacturing workflows, offer hands-on technical direction, and help the organization align with current Good Manufacturing Practices (cGMP), FDA rules, and broader international pharmaceutical requirements.
Key Duties
The role includes a detailed review of compliance, production systems, documentation, and team capability, with an emphasis on tablets, capsules, powders, and related solid dosage forms.
Responsibilities
- Check manufacturing activities against FDA expectations, cGMP standards, and international pharmaceutical rules.
- Study production processes used for tablets, capsules, powders, and other solid oral dosage products.
- Audit quality systems, recordkeeping, batch documentation, and SOPs to confirm they meet regulatory expectations.
- Suggest improvements that support inspection readiness, regulatory preparedness, and stronger operational performance.
- Coach production, quality assurance, and quality control staff on FDA compliance, cGMP, data integrity, and good pharmaceutical manufacturing practices.
Required Background
The organization is seeking someone with deep hands-on manufacturing experience and strong regulatory knowledge, especially around FDA rules and cGMP implementation.
Requirements
- At least 10 years of experience in pharmaceutical manufacturing.
- Strong command of FDA requirements, including 21 CFR Parts 210 and 211, along with current Good Manufacturing Practices.
- Proven expertise in solid oral dosage manufacturing such as tablets, capsules, and powder blends/formulations.
- Prior experience preparing for, assisting with, or responding to FDA inspections and audits.
- Solid understanding of quality systems, validation programs, documentation control, and regulatory compliance in pharma operations.
Candidate Profile
The preferred consultant is an experienced pharmaceutical manufacturing professional who can offer practical, high-value guidance to help a facility improve quality systems and meet international regulatory expectations.
Assignment Details
This is an on-site consulting engagement expected to last approximately one week. The text provided does not specify salary, stipend, number of openings, or application deadline.