Pharmaceutical Manufacturing Plant Manager
2 weeks ago
Position Overview:
The Pharmaceutical Manufacturing Plant Manager is responsible for overseeing and managing the setup of our drug manufacturing facility, with an emphasis on tablets, capsules, and metered-dose inhalers. They will ensure the facility's compliance with FDA standards, streamline operations, and contribute to our commitment to producing top-quality pharmaceutical products.
Key Responsibilities:
? Oversee the end-to-end process of setting up the drug manufacturing site, including facility layout, equipment procurement, and installation.
? Lead efforts to establish a metered dose inhaler manufacturing facility in line with industry standards.
? Coordinate with internal teams and external consultants for site qualification processes with the FDA.
? Manage timelines, budgets, and resources associated with facility setup and upgrades.
? Engage with regulatory bodies to ensure all manufacturing processes meet or exceed compliance standards.
? Collaborate with Quality Assurance and Quality Control teams to ensure product quality and compliance.
? Mentor, train, and oversee plant staff to ensure best practices in drug production and safety.
? Stay updated with the latest trends, techniques, and regulations in pharmaceutical manufacturing.
? Coordinate with R&D and supply chain teams for streamlined production processes.
? Continually assess and improve manufacturing workflows for efficiency and cost-effectiveness.
Required Qualifications:
? Bachelor's degree in Pharmacy, Chemical Engineering, or a related field. Advanced degrees preferred.
? Proven experience managing the setup of a drug manufacturing site, with a focus on tablets, capsules, and inhalers.
? In-depth understanding of FDA regulations and site qualification processes.
? Strong leadership and organizational skills.
? Ability to collaborate effectively with cross-functional teams and regulatory bodies.
? Problem-solving aptitude with an eye for detail and quality.
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