Associate Director - Sterile R&D Quality

Teva ,
Runcorn, Cheshire
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Overview

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: We are currently recruiting an Associate Director - Sterile R&D Quality to join the team in Runcorn on a Full Time, Permanent Basis to provide R&D Quality oversight of Sterile Research and Development projects at Runcorn UK, Zagreb Croatia, and Bucharest, Romania to ensure compliance, and to serve as the main R&D Quality Assurance contact for sterile projects. Essential duties and responsibilities: Lead, manage, and execute R&D QA Project Plans activities, ensuring compliance with Regulatory expectations and internal procedures. Develop and implement policies and procedures ensuring compliance with Regulatory expectations and internal procedures. Manage a Team of Associates at Sterile R&D sites within the Teva network. Manage and maintain R&D QA documentation associated with Sterile R&D projects. Observe and review development activities at Sterile R&D sites that may include but are not limited to manufacturing of development batches, testing of materials, process and methods validation, and tech transfer activities. Liaise as required with Operations QA contacts, and conduct QA technical audits of R&D laboratories Provide principle R&D QA point of contact for PAI's or development related inspections at Sterile R&D sites. Review and approve, where appropriate, project related documentation to include but not limited to development protocols and reports, change controls, manufacturing protocols and records, and specifications. Support the manufacture and release of Clinical supplies - providing QA checks on labels and protocols, release, distribution/IVRS issues and reconciliation as appropriate. Provide input and review product specification files, and perform QA review of documentation prior to final release. Perform QA audits on external suppliers against Teva procedures and standards Provide Quality review of CMC regulatory submissions when required. Represent R&D QA on global quality teams, and interact with other site R&D QA functions. Qualifications: Degree in Chemistry or Pharmaceutical Sciences Knowledge, Skills and Experience: Extensive experience in Quality Assurance and / or analytical or formulation pharmaceutical product development. Proven experience of working in a Quality Based GMP compliant organization. Experience in the development of sterile products. Proven experience of working in a quality based organization with a focus on and understanding of development activities related to Sterile products. Experience with Sterile CMC development and associated analytical procedures and processes. Knowledge of US and EU guidelines and implementation for CMC product development. Experience or desire to gain experience of auditing development CMC and clinical supplies activities. Function: Quality Sub Function: R&D Quality 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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws

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