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Mgr MS&T

Mgr MS&T
Date: Oct 2, 2018
Location: Forest, Virginia, US, 24551
Company: Teva Pharmaceutical Industries Ltd.
Company Info
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!
Job Description
OVERVIEW
Operate as senior-level MS&T technical resource and work collaboratively within the larger cross-functional site team. Lead and execute validation activities associated with equipment, process, and/or cleaning.
Drive improvements to overall MS&T operations. Use best practices to improve products, services and processes. Ability to resolve complex problems where precedents may not have been set. Ability to lead the work of project teams and provide formal training / mentoring to junior staff.
Prepare all technical validation documents / protocols, analyze data, and prepare final summary reports.
Review and disposition documentation for validation, change controls, GDr, CAPA?s, etc. Provide regular status on projects and activities as required. Identify, communicate, and mitigate risks to all responsible areas.
AREAS OF RESPONSIBILITY
+ Lead activities related to validation (including SOP?s, Safety, and Training). Communicate validation events to all affected departments, including Operations, Quality (QC & QA), and Production Planning.
+ Perform continual review of procedures in production to ensure process efficiency. Write and revise SOP?s as appropriate (including initial and periodic reviews).
+ Monitor processes to ensure strict accordance with documentation. Review and interpret analytical data. Evaluate process issues and determine performance trends, troubleshoot processes.
+ Write/issue validation protocols using information gained from technical services, research & development, and published references that clearly define the test functions to be executed.
+ Conduct validation activities and prepare the final report(s). Summarize and evaluate findings in a clear, orderly, and succinct manner.
+ Complete documentation related to CAPAs, GDr, CCM in timely manner
+ Perform all validation sampling using standard operating procedures to evaluate process, equipment, facilities, utilities, and/or cleaning process being evaluated.
+ Ensure cleaning executions are completed and communicated.
+ Provide on-going operational support and training to MS&T team members and key stake holders.
Qualifications
Education/Certification/Experience:
BS degree in related technical field with 7-10 years of experience in manufactuing, validation and/or technical services preferred. Experience leading technical projects.
Skills/Knowledge/Abilities:
Technical Qualifications
+ Thorough working knowledge of process, cleaning, equipment, facilities, and computer validation experience preferred. Emphasis on process validation with desire to learn additional skills.
+ Knowledge of pertinent technical information related to an assigned project.
+ Ability to identify & resolve process problems.
+ Ability to design and execute experiments to troubleshoot issues.
+ Working knowledge of operation, maintenance, and utility of all manufacturing and/or packaging equipment for assigned projects.
+ Thorough familiarity with cGMP?s, SOP?s, and relevant government regulations.
+ Ability to write validation protocols and reports.
Communication Qualifications
+ Ability to communicate effectively and confidently with individuals at all levels of the organization.
+ Ability to initiate and lead technical projects and manage all aspects of the work required for completion.
+ Ability to identify potential issues, review and judge data, and provide suggestions for improvement.
+ Ability to clearly present data, ideas, and updates on projects at team meetings.
+ Ability to track multiple projects; ability to prioritize multiple urgent tasks while performing daily duties.
Working knowledge of Microsoft Office applications.
Function
MS&T
Sub Function
Technical Transfer
Process Engineering
Reports To
In process of validation
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: Lynchburg
Nearest Secondary Market: Virginia


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