Senior Specialist Quality at Viatris in SUGAR LAND, Texas

Job Description:

Organization

-Mylan Institutional Inc. (Sugarland)Senior Specialist Quality-21000352At 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.
  

Every day, we rise to the challenge to make a difference and here's how theSenior Specialist Qualityrole will make an impact:

Key responsibilities for this role include:

• Oversee quality functions for ERP systems (SAP) for updating material data and verifying raw materials and components.


• Oversee, routinely engage in, or manage various electronic systems to ensure compliance in the facility's quality operations:
  
  
  
  • Datamyte In-process software
  
  
  • Trackwise - Change controls, investigations, complaints management/investigations
  
  
  • Documentum
  
  
  • LIMS
  
  
  • Serialization batch software and processes
  
  
  • SAP
  
  
  
  


• Assist in managing DEA/controlled substances inventory and files as well as performing planned inventory verifications of controlled substances on an annual and biennial basis.


• Manage vendor files and update vendor information, as necessary.


• Perform batch record review and dispositioning of materials, as necessary and perform production line clearance when needed.


• Assist with Investigations, External audits, Health Authority inspections (FDA, DEA), and internal audits.

The minimum qualifications for this role are:

• Minimum of a Bachelor's Degree with major/emphasis in physical or natural sciences (or equivalent) and 2-4 years of experience in a commercial pharmaceutical environment. A combination of experience and/or education will be taken into consideration.


• Must possess practiced knowledge of US cGMP pharmaceutical regulations in particular, 21 CFR * 210 and * 211. Must have knowledge of hazardous/safety material handling. Must be familiar with requirements of 21 CFR * 11 (Electronic Records; Electronic Signatures).


• Must possess written and verbal communication skills, interpersonal skills, strong work ethic, strong attention to detail skills, consensus gathering skills, strong organizational and problem-solving skills. Computer skills, such as Microsoft Office including Word, proficient in Excel and internal e-mail systems (Outlook). Strong knowledge of ERP systems (i.e. SAP) would be a plus as well as other compliance electronic systems.


• Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence. Ability to work with peers and communicate basic concepts. Technical writing skills in English are required.

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.

Schedule

-Full-time

Job Posting

-Apr 6, 2021, 7:59:42 PM

Unposting Date

-Ongoing

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