Germer International - Pharmaceutical Recruiting · 1 week ago
Quality Inspection Readiness Lead
Vermont, United States
Full-time
Onsite
Senior Level, Lead/Staff
$90K/yr - $130K/yr
10+ years expGermer International is a Fortune 500 pharmaceutical company known for its commitment to global health access through innovative therapies. The Quality Inspection Readiness Lead will be responsible for overseeing self-inspection plans, conducting inspections, and ensuring compliance with quality standards and regulations.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Les Schafer 484-684-6154
Responsibilities
Creation and tracking of the site self-inspection plan, inclusive of self-inspection scheduling and development of self-inspection agenda
Liaising with Site Leadership and Global Operations Auditing to gain alignment on self-inspection plan schedule and scope
Leading and participating in site self-inspections. Ensuring each self-inspection is appropriately recorded and communicated. Performing frequent unplanned and planned walk through inspections of the facility
Evaluation and tracking of CAPA items from self-inspections and providing guidance to site functions to ensure robust, holistic actions are developed. Ensuring that CAPAs are verified for effectiveness
Prepare annual trend reports for site self-inspection data and collaborate across Company to identify Global and/or regional opportunities. Facilitate bi-monthly reviews with site and global personnel to discuss site learnings and opportunities
Responsible for Site Audit Module and associated processes and procedures
Support overall site Inspection Readiness Plan, participating as required in site Board of Health inspections
Participate in Global Operations Audits of Company facilities
Perform external audits of third party suppliers as aligned with site and GOA requirements
Participate in global audit training and disseminate relevant detail to site teams. Provide training and coaching as required to broader site self-inspection team
Support any of the site quality culture initiatives
Qualification
Required
Must possess extensive knowledge and understanding of pharmaceutical cGMP and global government regulations, including Company policies, procedures and associated documents (corporate, regional, site), local regulations, US FDA, WHO EMA, ICH and ISO 9001 (as applicable to the site)
Possess an in-depth knowledge of quality system requirements; including a demonstrated ability to evaluate and apply global GMP's to support evaluation and enhancement to site systems and processes
Minimum of a Bachelor's degree in Science, Engineering, or related technical discipline with at least 10 years' experience in a GXP setting, extending across a range of functions inclusive of Quality Assurance. However, a combination of experience and/or education will be taken into consideration
Company
Germer International - Pharmaceutical Recruiting
Welcome to Germer International! We're a Life Sciences search & placement firm that focuses on building long-term partnerships with small and mid-sized companies across the country.
11-50 employees
Funding
Current Stage
Early StageRecent News
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