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Viatris · 2 weeks ago

Site Self Inspection Lead, Quality Assurance – 1st shift

St Albans, VT

Full-time

Onsite

Senior Level, Lead/Staff

$95K/yr - $193K/yr

10+ years exp

Viatris is a global healthcare company committed to empowering people to live healthier lives. The Site Self Inspection Lead will be responsible for creating and managing the site self-inspection plan, leading inspections, and ensuring compliance with quality standards and regulations.

BiotechnologyHealth CareLife SciencePharmaceutical

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 Viatris 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 Viatris 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

CGMP knowledgeQuality system requirementsPharmaceutical regulationsBachelor's degree in ScienceGXP experienceTrainingCoachingInspection readiness

Required

Must possess extensive knowledge and understanding of pharmaceutical cGMP and global government regulations, including Viatris 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