1+ months

MS&T Specialist - Validation

Davie, FL 33314
Company Info

If youre like people at Teva, you dare to be different. Were 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. Tevas Davie and Sunrise (Florida) production sites are two of our largest launch facilities.   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!

 

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

This position will focus on managing the validation processes within site operations in order to facilitate successful on-time product launches and lifecycle events (including various pre-requisites and post validation commitments).

  • Lead and assist project teams responsible for PQ of equipment, pre-validation, validation, CPV and cleaning validation
  • Author, execute or review or approve documentation for validation (PV and CV)
  • Create and lead project tracking systems
  • Lead and support risk management processes for product and processes
  • Author, review or approve (as needed) investigation reports, protocols batch records and CMC documentation

Knowledge and experience in use of various solid oral dosage manufacturing and packaging technologies Knowledge of current

  • and advanced validation strategies using statistics, current regulatory landscape and agency expectations for pre-validation, PPQ and CPV including validation of oral solid dosage forms using novel manufacturing technologies
     
Qualifications
  • A Master of Science or PhD degree in Chemistry, Pharmaceutical Engineering, Pharmaceutical Manufacturing, or Pharmaceutical Technology  is required
  • Proficiency with statistics (use of Minitab or JMP), NIR and project management tools is required
  • Experience using Excel for data mining and analysis is required
  • Experience with novel manufacturing technologies (minimum two) melt extrusion, spray drying, spray congealing, extrusion spheronization, laser drills, nano particulates, continuous manufacturing, NIR or PAT
  • Minimum 3 years experience in validation of oral solid dosage forms including risk management
  • Excellent verbal, written, and interpersonal skills required
  • Work with minimal supervision
  • Comply with FDA regulations at all times
  • Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint
  • Must be able to maintain the highest levels of confidentiality, integrity and discretion
Function
Manufacturing
Sub Function
Technical Transfer
Reports To

Senior Director MS&T

Tevas 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.

Categories

Posted: 2020-03-23 Expires: 2020-06-18

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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MS&T Specialist - Validation

Teva Pharmaceuticals
Davie, FL 33314

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