Cincinnati, Ohio, US, 45213
Company: Teva Pharmaceuticals
If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.
Teva’s Cinicinnati, Ohio production sites are one of our solid manufacturing and supply chain operations.
We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success. Be part of it!
In this role, you will:
- Prepare process validation and performance qualification protocols, report and analyze data including statistics
- Monitor validation/re-validation, and perform qualification processes to ensure strict accordance with documentation
- Perform routine to complex investigations
- Assure compliance to GMP requirements for oral solid and other dosage forms including combination products
- Perform steps to evaluate material changes and alternate materials
- Perform hands-on process/product scale-up studies on specifically assigned products
- Utilize knowledge in the areas of formulation development and process optimization using pharmaceutical processes such as polymer processing, terminal sterilization, wet granulation (high shear and fluid bed), pellet processes, direct compression (v-blenders and container blending systems), tablet compression, encapsulation, tablet coating, etc.
- Contribute to process improvements
- Resolve problems using existing solutions and new perspectives
- Provide informal guidance to junior staff
- Work both independently, and with more experienced mentor
- Act as a resource for colleagues with less experience
- Bachelor’s Degree in Science related - required. Engineering strongly preferred.
- 10+ years Pharmaceutical validation (Process validation) required
- Specialized or Technical Knowledge Licenses, Certifications needed
- Proficient use of specified computer software
- Ability to work under minimal supervision and ability to work collaboratively required
- Ability to present information verbally and in writing to peers, work groups and management
- Sound interpersonal skills
- Working knowledge of related equipment and processes required
- GMP and FDA guidelines required.
- Apply working knowledge of regulatory requirements and other related disciplines.
- Understanding of departmental working relationships