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.
Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist Operations Support role will make an impact:
Key responsibilities for this role include:
· Provides leadership and support for authoring/reviewing documents related to standardized work practices and operational requirements for the cleaning, running and set-up of Mfg/Pkg lines (ie SOPs, Work Instructions, BPRs, protocols, training documentation, etc).
· Provide support in authoring and leading change control related projects for existing equipment and processes. Assures coordination of efforts and adequate documentation is provided for timely closure of change controls.
· Facilitates and leads investigational activities to determine root cause and appropriate corrective/preventive actions.
· Performs routine process monitoring, document review and trending of previous events to identify opportunities for continued improvement.
· Collects, analyzes, and interprets data from production systems and processes. Recommends action plans for process improvements where appropriate.
· Authors reports and project plans to support departmental projects and initiatives.
· Participate/Leads projects and CAPA related to Right First Time initiatives and continuous improvements.
· Functions as a department representative and liaison for product transfers, supporting operational readiness for commercialization of new products.
· Supports manufacturing and packaging in inspection readiness and quality culture related projects/initiatives by performing management directed evaluations and self-inspection activities.
· Provides leadership and support for employee training and development, within the Mfg/Pkg Operations Department.
· Perform other duties as assigned.
The minimum qualifications for this role are:
· Minimum of a Bachelor’s Degree (or equivalent) and 2 years of related experience. A combination of experience and/or education will be taken into consideration.
· Must also have working knowledge and understanding of 21 CFR parts 11, 210, 211 and 820. Must have the ability to apply that knowledge with sound judgement in position appropriate decision making. Must possess knowledge and understanding of manufacturing and packaging processes, include general understanding of equipment functionality and inspection systems. Must possess knowledge and understanding of systems and process related to document control, training, investigations and CAPA. Must possess functional knowledge and understanding of statistical methods for product quality and structured problem-solving methods.
· Ability to solve equations, apply technical mathematical concepts, and perform complex computations.
· Must possess good interpersonal and communication skills. Must possess excellent problem-solving skills, ability to lead conflict resolution and demonstrate a high degree of professionalism with sensitive information. Must have excellent time management skills and be able to work effectively and efficiently to due dates. Must be highly organized and function as a team player. Must possess technical writing skills. Must be proficient in computer systems such as Microsoft Office, Minitab, TrackWise® (Incident, Investigations and CAPA workflows), D2 (Author experience), Document Change Control Systems and adept at learning new computer based systems.
Exact compensation may vary based on skills, experience, and location. The salary range for this position is $55,000 - $105,000.
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.