- Ensure the principles and guidelines of cGMP have been met during manufacturing, packaging and testing operations.
- Verify all batch related documentation is compliant with the requirements of the regulatory authorities.
- Review and certify batches in line with business shipment schedules.
- Responsibility for planned changes or deviations being supported by appropriate sampling, inspection, testing and compliance adherence, in line with the requirements of the regulatory authorities.
- A degree in a Science based discipline.
- Membership of appropriate professional body.
- Significant experience in a senior Quality role, a Quality Leader, in a modern manufacturing environment.
- Registration as a Qualified Person, with acceptability to the Licensing Authority.
- Experience with aseptic processing, sterile medicinal products and combination products is highly preferable.
- We're looking for a strong personality that is driven to set and deliver high performance standards relating to quality, safety, cost and customer service
- A creative, visionary thinker that will proactively make suggestions/changes that take a long term strategic view for the overall improvement of quality processes
- A confident communicator that defends their opinions to internal stakeholders
- You'll be part of a small QP team, which translates to having a big influence across the business, including (but not limited to) involvement with initiatives to improve the site and the introduction of new products
Qualified Person - Preston Brook, United Kingdom - Teva Pharmaceuticals
Description
Who We Are
We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us. We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world and we currently have a fantastic opportunity for a Qualified Person to join our team on a Full Time, Permanent basis in Runcorn.
At Teva Runcorn, we develop, manufacture and market innovative and affordable medicines, specialising in sterile liquid products mainly used for treating respiratory conditions using Blow-Fill-Seal technology as well as injectable Combination Products such as our MS treatment Copaxone.
A Day In The Life Of A Qualified Person
You'll be performing final QP Batch Certification daily to ensure that all products released to market comply with the requirements of the Manufacturer's Licence, Marketing Authorisations, ANDAs, Technical Agreements, CE certification, in accordance with EU, USA, or other requirements e.g. Russia, Brazil, Canada.
Key Responsibilities
Who We Are Looking For
Do you have:
Are you:
If so - we would value hearing from you