Site Self Inspection Lead, Quality Assurance - 1st Shift

Regulatory Toolkit; St. Albans (VT); Vor Ort; USD 95.000 - 193.000; Vollzeit

Zusammenfassung

Mylan Technologies, Inc. in Vermont seeks a Site Self Inspection Lead to develop and manage the site self-inspection program, schedule audits, and coordinate with Site Leadership and Global Operations.

You will lead inspections, track CAPAs, prepare trend reports, participate in audits, and train site teams on inspection readiness and quality culture.

Qualifikationen

• Extensive knowledge of pharmaceutical cGMP and global regulations (FDA, EMA, ICH).
• Strong understanding of quality system requirements and GMP processes.
• Bachelor's degree in Science or Engineering with 10+ years in a GXP environment.

Aufgaben

• Create and track the site self-inspection plan, including scheduling and agenda development.
• Liaise with Site Leadership and Global Operations Auditing for alignment on plan scope.
• Lead and participate in site self-inspections and document findings; conduct walkthroughs.
• Evaluate CAPAs from inspections and guide site functions to robust actions; verify effectiveness.
• Prepare annual trend reports and coordinate global/regional improvements; facilitate reviews.
• Support Site Audit Module, inspections readiness, and audits of facilities and suppliers.
• Provide training and coaching to the site self-inspection team; promote quality culture initiatives.

Kenntnisse

cGMP knowledge

Quality system

GXP experience

Ausbildung

Bachelor's degree in Science/Engineering

Jobbeschreibung

Mylan Technologies, Inc.

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here’s how the Site Self Inspection Lead will make an impact:

Key responsibilities for this role include:

• 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.

The minimum qualifications for this role are:

• 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.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.