Address
Form of work5100 Mylan Technologies, Inc.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
- Access - Providing high quality trusted medicines regardless of geography or circumstance;
- Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
- Partnership - Leveraging our collective expertise to connect people to products and services.
Key responsibilities for this role include:
- Lead the Release Preparation activities by reviewing Intermediate and Finished Product Batch Records.
- Back-up the primary Release Officer by approving and releasing Finished Products that conform to specifications for distribution on an as needed basis.
- Notify Quality Management of batches with non-conformances and assure that non-conforming batches are recommended for rejection and appropriately dispositioned.
- Maintain the Quality Systems and procedures supporting departmental responsibilities and cGMP.
- Assure deviations are appropriately reported, investigated and completed. Participate in the investigations of deviations as needed.
- Maintain and coordinate the mock recall program for the site.
- Develop and author procedures that describe the critical functions performed by the department.
- Assure that written procedures defining departmental functions are appropriate, agree with current practice and cGMP, and are followed.
- Maintain and report Quality Metrics related to Batch Release Function.
- Train and develop site personnel in Quality Systems.
- Assist in preparation of documentation prior to and during FDA, MCA and vendor audits. Provide support in closing out observations from audits.
- Interact locally with operator and management level employees and interacts with affiliates and the distribution center as needed.
- Identify improvement opportunities and leads departmental project teams geared toward continuous improvement of the quality system.
- Perform other duties as assigned.
- Bachelor's degree, 4 years of relevant experience, experience in a GMP environment, and a fundamental understanding of Quality Systems and cGMP. However, a combination of experience and/or education will be taken into consideration.
- Must possess working knowledge of Quality systems for the Pharmaceutical Industry, cGMP, ICH and Pharmacopoeia (USP, EP) requirements. Must adhere to Company and Department policies and procedures as well as government regulations. Requires understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs).
- Must adhere to Company and Department policies and procedures as well as government regulations. Requires understanding of Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practices (cGMPs).
- Must possess strong basic math skills, ability to communicate (written and verbal). Must have experience in development of methods for HPLC and GC, plus familiarity with laboratory automation equipment.
- Position functions semi-autonomously.
- Normal office and lab environment.
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.
