Introduction:
Our client is the pharmaceutical industry.
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Responsibilities:
- Responsible for building and managing the Quality Management System, as well as developing the in-depth knowledge of the team on the regulatory requirements established by FDA GMP, as applicable to the activities conducted at the site.
- Supporting the transfer to commercial operations, including pilot manufacturing and stability expiration dating.
- Lead the quality assurance program, holding self and others accountable for ensuring compliance with applicable elements of the FDA GMP regulations for Drugs.
- Facilitate the establishment and maintenance of a suitable document management system
- Direct and facilitate investigations as needed for process failure, test failure, stability failure, CAPA and deviations
- Establish appropriate site quality metrics consistent with business objectives and periodically report progress and effectiveness to management and staff
- Review and approval or reject all finished goods, procedures, specifications, materials, protocols, and reports related to drug product that is required to comply with GMP
- Represent the Trumbull site during FDA inspections, being the primary point of contact for Trumbull during inspections at manufacturing sites.
- Participate in / supports (depends on project) Quality risk assessments for innovations.
- Supports changes to existing and new materials suppliers through activities that assure quality / hygienic control processes are in place and operating effectively, e.g., follow up on audit action plans.
- Drives internal audits and subsequent programs to ensure GMP compliance and procedures are followed throughout the site.
Requirements:
- A Ph.D., M.S., or B.S. in Regulatory Affairs, Pharmaceutical Quality Management, Chemistry, Biology, Engineering, or related field and 5+ years of leadership experience in GMP or ISO.
- Strong working knowledge of FDA GMP and HACCP.
- Excellent communication skills and the interpersonal skills to work within a diverse and rapidly changing work environment, communicating both with senior managers and colleagues to ensure effective implementation and compliance of the quality program.
- A proven track record to establish and implement, as well as lead and manage a GMP compliant quality program is essential.
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