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Company: Teva Pharmaceuticals
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. Join us on our journey of growth! For more on Teva, check us out at www.tevapharm.com or www.tevausa.com.
This position is located near the University of Utah in Research Park at 575 Chipeta Way, 84108
Under supervision of management, the Pharm Tech Specialist III performs activities related to critical aspects of products and processes. Prepares validation protocols. Performs complex technical and specialized duties. Assists in conducting efficiency studies and in the identification of process improvement opportunities. Participates in project coordination activities. Provides lead direction and training to lower level staff.
- Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
- Provides assistance in troubleshooting to manufacturing and packaging areas.
- Interfaces with Quality Assurance and Research and Development (R&D) on process requirements for new and current products.
- Works in conjunction with maintenance department to identify, recommend and implement the upgrade of current equipment and the purchase of new equipment within regulatory requirements.
- Analyzes new and existing equipment, recommends equipment modifications as needed or validation optimization.
- Performs studies to support necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas.
- Assists with on-site transfer projects and product scale-up activities.
- Recommends improvements in manufacturing and control systems.
- Reviews mechanical, specifications in manufacturer and blue print form, and identify critical parameters.
- Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements.
- Review and approve protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
- Assures that protocols are approved through proper channels; writes and revises validation protocols.
- Executes validation protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
- Interacts with all effected personnel in the execution of protocols and gathering of test data. Assures that all test data is gathered and recorded in accordance with cGMP requirements.
- Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria.
- Writes final reports and assures that they are approved through proper channels.
- Coordinates resources from engineering, research and development, technical services, quality assurance and production personnel assigned to specific projects. Furnishes direction to engineers and technicians with regard to project requirements. Develops and communicates project timelines and status.
- Reviews and critiques investigation reports, protocols batch records and CMC documentation.
- Provides timely updates to management on the status of various projects.
- Provides technical training and assistance to others.
- Provides coaching and assistance to direct reports in the areas of disciplinary action, employee training, problem resolution and work assignment delegation.
- Complies with all GMP and safety requirements, SOP’s and Company policies and procedures.
- Performs related duties as assigned.
Bachelor’s degree in Science or related field from an accredited college or university and seven (7) to ten (10) years of experience; or an equivalent combination of education and experience. Graduate degree preferred
- Knowledge pharmaceutical manufacturing principles, practices and applications
- Ability to work and contribute in a positive, collaborative and dedicated team environment
- Knowledge of pharmaceutical products equipment qualification/calibration concepts.
- Knowledge of pharmaceutical raw material and finished product tests, results and interpretation
- Experience in writing clear and concise technical documents (Batch Record, Change Control, Protocols, Summary and Evaluation reports)
- Project management experience; ability to simultaneously manage multiple projects, duties, and assignments.
- Ability to read, write and speak English in order to complete and generate training, reports and or revise or update documentation files, databases, and logs accordingly.
- Ability to lift up to 25 lbs, climb stairs & ladders, work in moderate to loud noise environment and wear GMP appropriate attire as required.
- Intermediate skills in Microsoft Office Suites (Word, Excel, Access, PowerPoint, MS Project)
- Intermediate statistical analysis, computations, and test methodology experience; Knowledge of JUMP or MINI TAB required.
- Demonstrated knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: Salt Lake City
Executive / senior industry position
Salt Lake City , United States