Validation Engineering Compliance Analyst III

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Validation Engineering Compliance Analyst III position is filled by a professional who possesses expert knowledge in commissioning, qualification, and validation of computerized, and equipment systems, process automation validation and technical technology transfer activities. The candidate possesses expert compliance and Regulatory knowledge and skills necessary to qualify and validate in current Good Manufacturing Practice (cGMP) and System Development Life Cycle (SDLC) regulations for commercial and clinical biopharmaceutical manufacturing equipment, control systems data acquisition and reporting systems. The candidate has experience in writing, executing and reporting validation documents, including remediation process strategy to assure data integrity, cGMP validation compliance and appropriate documentation evidence to verify compliance activities are effective, accurate and complete.

The incumbent works with manufacturing and technical support groups to assure the quality, accuracy, and integrity of data in the qualification of Automation and Equipment Qualification and Validation. The position is responsible for validation and provides an independent role in the execution and reporting of key documentation, which may include policies, procedures, work instructions, acceptance criteria, master validation plans, qualifications, reports to GMP computerized systems that impact patient safety, product quality or data integrity.
The incumbent applies experience and excellent communication skills within a collaborative environment to assure that the GMP Quality culture are embraced by the site to enable a commitment to continuous quality improvement and embrace a permanent inspection ready attitude.

The position involves expert knowledge of the Quality Management System (QMS) and its implementation in relation to GAMP 5, SDLC, ASTM E2500, 21 CFR Parts 210, 211 and 11, Annex 11, Annex 4, Annex 15, and Validation guidance (FDA, EU, HC, MHRA, etc.).

Essential Responsibilities

• Provides validation support to the commissioning, qualification, and validation of GMP computerized systems (process equipment, control systems, PLC/SCADA, Lab systems, BAS, HVAC, analytical instrumentation, business information systems) with an understanding of CSV and SDLC compliance in a biopharmaceutical Facilities/Utilities, Laboratory, Packaging, Manufacturing, Warehouse QSIT environment.
• Supports the preparation, execution, review and reporting of Qualification and Validation documentation, including, but not limited to: Validation Planning, System Requirements, System Qualification and Verification, Deviation and CAPA, Validation Summary Report, Release of System for Use memo, procedures related to system use and continued validation state, retirement and decommissioning, Quality Risk Management (assessments addressing patient safety, product quality, data integrity).
• Support GMP compliance and inspection readiness initiatives related to CSV and data integrity.
• Ensure activities are performed/completed using current Good Manufacturing Practices.
• Utilize Quality Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.
• Provide expert advice, mentoring and training for site employees for activities that support GMP studies and clinical and commercial manufacturing.

Additional Compliance Responsibilities

• Serve as Validation resource, representing BOSS on teams in support of assignments.
• Support cross functional department customers in a manner which is clear in approach, communication and action.
  

Your experience and qualifications

• BS/BA or Undergraduate degree in applicable discipline.
• Minimum 2 years of experience with Bachelors.
• Expert Knowledge in Computerized Systems including System Development Lifecycle.
• Expert Knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP, Health Canada regulations, policies & guidelines) required.
• Management/Leadership Experience preferred.

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