Teva Pharmaceutical Industries Copiague , NY 11726
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. Join us on our journey of growth!
Under general supervision, performs advanced journey-level duties in reviewing specifications and determining the critical aspects of facilities, utilities and computer systems, and manufacturing equipment with regard to product and process quality; prepares qualification protocols; performs technical and specialized engineering duties.
Role and Responsibilities
Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Reviews electrical, mechanical and software/computer specifications in manufacturer and blueprint form, and identifies critical parameters.
Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements.
Writes protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems or equipment, and ensures that protocols are approved through proper channels.
Researches and recommends changes; and writes and revises validation protocols.
Executes validation and qualification protocols per related SOPs and assures that acceptance criteria related to validation and qualification protocols are met.
Analyzes new and existing equipment, recommends equipment modifications as needed for process and validation optimization.
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 validation projects.
Performs deviation investigation and CAPA implementation.
Maintains and perform validation assessments.
Develops and communicates project timeline and status.
Ensures compliance with all Company policies and procedures, including safety rules and regulations.
Performs related duties as assigned.
Knowledge & Skill Requirements:
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws, codes, regulations and regulatory requirements.
Pharmaceutical principles, practices, and applications.
Pharmaceutical quality control and manufacturing processes.
Principles and practices of qualification and validation.
Techniques or sampling, testing and measuring, and principles of mathematical and statistical computations.
Mechanical and electrical concepts.
Ability to analyze and troubleshoot problems, identify solutions, recommend and implement methods, procedures and/or techniques for resolution.
Responding to inquiries from management, employees and regulatory agencies.
Communicating clearly and concisely, both orally and in writing.
Managing multiple projects, duties and assignments.
Analyzing problems, identifying alternative solutions, projecting consequences of proposed actions and implementing recommendations in support of project completion and goals.
Qualification & Education Requirements:
Equipment Maintenance Technical Specialty
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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: Long Island
Nearest Secondary Market: New York CIty