Job Description:
Organization
-Mylan Institutional Inc. (Sugarland)Specialist, Quality Assurance -21000351At 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:
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Access - Providing high quality trusted medicines regardless of geography or circumstance;
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Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
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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 theSpecialist, Quality Assurance role will make an impact:
Key responsibilities for this role include:
- Performs quality assurance documentation record review and batch disposition for:Finished products, Bulk pharmaceutical products, Stability, Raw Materials used in the manufacture of pharmaceutical products and the Packaging components used in the production of pharmaceutical products.
- Determines the disposition (i.e. release or rejection statuses) for packaging components (container/closures), raw materials, bulk products and finished packaged products.
- Prepares technical reports and supports product transfers
- Assists in QA product complaint activities which include: Daily electronic reviews - Logging - Investigating- Trending and providing and compiling data for deviations and/or investigations
- Assists on an as-needed basis with QA operations activities - Room releases, In-process checks, and generation of labels, and/or raw materials sampling.
- Assists in updating Standard Operating Procedures and providing input on QA improvements based on organizational needs.
- Supports Health Authority inspections by conducting data compilation and document retrievals as required.
The minimum qualifications for this role are:
- Minimum of a Bachelor's degree (or equivalent) and 2 years of experience.However, a combination of experience and/or education will be taken into consideration. Experience in a pharmaceutical and/or medical device industry is required.
- 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, Excel and internal e-mail system.
- Must possess knowledge of pharmaceutical and medical device regulations. Must have knowledge of hazardous/safety material handling.
- Ability to work a day split-shift.
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.