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Quality Analyst III - 6003

Date: Jan 10, 2019

Location: Elizabeth, New Jersey, US, 07201

Company: Teva Pharmaceuticals

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

The Quality Systems Analyst III is responsible for supporting the SDLC lifecycle for computerized systems validation within Quality Control and Quality Assurance, supporting global/local system deployments, computer systems validation, system categorization utilizing the GAMP 5 methodology, inspection readiness, supporting client audits and regulatory inspections, risk assessments, cGMP issues and QMS gap remediation. Additionally the Quality Systems Analyst III is responsible for authoring and executing SDLC lifecycle documents and providing admin support for computerized systems in Quality Control and Quality Assurance at the site level.

 

Essential Duties/Functions:

  • Coordinates computerized quality systems integration activities between corporate/global functions at the site with responsibilities such as site system validation and site system ownership.
  • Coordination of site SME training, site acceptance testing development and working with IT to develop the appropriate interfaces, user access.
  • Supporting systems through operational phase activities such as period review, data backup and restore, user access review and decommissioning.
  • Provide support for new system implementations to address quality systems related matters with potential escalation to global IT resources.
  • Responsible for the authoring and execution of all System Development Lifecycle (SDLC) deliverables associated to local computer systems including qualification/validation plans, functional/end user requirements, risk assessments, test plans, test summary reports, test scripts, data migration plans/reports, traceability matrices and validation summary reports.
  • Provide direct support for FDA inspections and third party audits for matters relating to computerized systems (maintaining GxP Regulated Computerized Systems Inventory) within Manufacturing, Quality Control and Quality Assurance.

Qualifications

  • Bachelors of Science degree in relevant field or equivalent experience is required.
  • A minimum of 10 years of experience in an FDA regulated industry in pharmaceutical Quality Control, Quality Assurance, Quality Systems or Manufacturing.
  • A minimum of 8 -10 years of experience working directly with computerized systems and supporting the SDLC process.
  • Experience in authoring or executing qualification protocols, non-conformities, change requests, SOPs, validation plans, risk assessments and validation summary reports is required.

 

  • Must have the ability to work independently and make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands.
  • Knowledge of Regulatory Procedure FDA 21 CFR Part 11 with good understanding of GxP related processes.
  • Knowledge of GAMP 5 Model.
  • Ability to adapt to a fast and dynamic environment.
  • Ability to follow procedures and produce/maintain supporting documentation.
  • Excellent written, oral and interpersonal communication skills.
  • Excellent time management skills.
  • Highly self-motivated, self-directed, and attentive to detail.
  • Exposure to Laboratory and/or Quality systems such as Chemstation, Empower, LIMS, QAD, JDE, etc.

Sub Function

Manufacturing Quality Assurance

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.


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