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!
We are currently recruiting a Senior R&D QA Steriles Specialist to provide Sterile Expertise in Quality Assurance to the New Product Development and Technical Support functions. Provide the oversight to ensure new products and processes are designed, developed and introduced to the respective manufacturing site in compliance with current Good Manufacturing Practices. In particular to provide ongoing expert advice and problem solving on aseptic processing manufacturing, filling and packaging activities; facilitating the development of robust policies, processes and procedures in support of the Production processes to ensure compliance with global, site and regulatory expectations.
- To support activities within the Generic R & D (New Product Development) Department, Technical Support functions and external Teva partners, to ensure that current Good Manufacturing Practices, Teva Global Policies and Standards and relevant Regulatory Authority requirements are met.
- Represent R&D QA on global quality teams, and interact with other site R&D QA functions, including review of systems and processes to ensure best practice.
- To review and approve all documentation generated in support of new products and processes to ensure compliance with regulatory requirements.
- To provide support to the lead Quality representative for Regulatory inspections for new product approvals (i.e. Pre-Approval Inspections, Bioequivalence inspections).
- To provide audit expertise to the NPD vendor assurance programme and perform QA audits on external suppliers against Teva procedures and standards
- Review and approve, where appropriate, project related documentation to include but not limited to test methods, manufacturing protocols and records, and specifications.
- Ensure all OOS results and unplanned deviations with respect to Generic R&D are fully investigated and documented and any corrective and preventative actions identified are implemented.
- Support the manufacture and release of Clinical batches - 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.
- Provide Quality review of CMC regulatory submissions when required.
Knowledge, Skills and Experience
- Minimum degree qualified in a pharmaceutical discipline with evidence of ongoing professional development.
Closing Date For Applications
- Extensive experience working in a Quality Assurance role in a modern manufacturing/R&D environment within the pharmaceutical industry in a similar Steriles environment is essential
- Experience in steriles operations to EU and FDA standards.
- Strong experience of new product introduction from development to final approval.
- Experience with reviewing and assessing the suitability of new product licence dossiers/submissions.
- Experience with Regulatory inspections (either hosting or being a key presenter).
- Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists.
- Monday 14th September 2020
Quality Sub Function
R&D Quality Already Working @TEVA?
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