1+ months

Application Support Professional

Salt Lake City, UT 84111
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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

Summary:  Under limited supervision, participates as a team member in qualification/validation activities related to laboratory instrument/equipment systems including computer systems.  The position additionally provides lead duties by providing technical assistance and training.

  • May supervise, coordinate, prioritize and lead the daily activities of a group of qualifiers/validators and schedule their workloads.
  • Designs qualification/validation plans and protocols; researches and writes documents in support of project directives for the qualification/validation of instrumentation/computer systems.  Performs and may oversee the development of qualification/validation activities for instrumentation and supporting software.
  • Develops and oversees the creation of Standard Operating Procedures related to instrumentation including the administration of related supporting software.
  • Maintains appropriate documentation of records, report sheets and laboratory logbooks as required by Standard Operating Procedures (SOPs).
  • Provides scientific and technical leadership to junior staff members to ensure project deadlines and performance standards are met.  Collaborates closely with Supervisor to set priorities and reach objectives.
  • Prepares and presents written reports on qualification/validation activities.
  • Provides formal and informal training to laboratory personnel on instrumentation usage.
  • Selects, justifies, and implements appropriate instrumentation, computer systems, and procedures to achieve product development support objectives.
  • Ensure compliance with all Company policies and procedures, including safety rules and regulation. 
  • Pertinent SOPs related to analytical instrumentation qualification and computer system development life cycle.
  • FDA, CGMP, and SOP regulatory rules, regulation and guidelines.
  • Business, scientific and personal computer hardware and software applications.
  • Supervision, leadership and training practices and methods.
  • Responding to inquiries from management, employees and regulatory agencies.
  •  Training of junior staff.
  • Leading the activities of technical personnel; making decisions and satisfying the needs of a qualification/validation program.
Qualifications

Minimum Qualifications

Bachelors Degree in Science, Information Technology, or related scientific field from an accredited college or university, and 5 to 10+ years  related pharmaceutical systems or laboratory experience desired, or an equivalent combination of education and experience.

Knowledge of 21CFR part 11 and GAMP5 Guidance a plus.

Pharma systems validation experience desired.

Function
Information Technology
Sub Function
Application Support
Reports To
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.

Posted: 2019-07-03 Expires: 2020-01-06

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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Application Support Professional

Teva Pharmaceuticals
Salt Lake City, UT 84111

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