Qualified Person - Aseptic and/or Steriles

Location Cheshire
Discipline: Quality Assurance
Job type: Permanent
Salary: ££75,000-90,000 DOE
Contact name: Katie Dunbar

Contact email: katie.dunbar@rbwconsulting.com
Contact phone: +44 1293 584 300
Job ref: 24569
Published: 21 days ago
Expiry date: 29 Mar 2023 11:59
.RBW are recruiting on behalf of a global pharmaceutical company, for a Qualified Person to join their team on a permanent basis. As a Quality leader, this role has a big influence including involvement with initiatives to improve the site and the introduction of new products, as well as daily QP duties.
The role will suit someone with a strong personality and confident communicator, who is driven to set high performance standards relating to quality, safety, cost and service.
Key Responsibilities
  • 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.
  • 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.
  • To proactively make suggestions/changes that take a long term strategic view for the overall improvement of quality processes

Essential Experience and Skills
  • A degree in a Scientific discipline.  
  • Registration as a Qualified Person, with acceptability to the Licensing Authority and Membership of appropriate professional body.      
  • Experience with aseptic processing and sterile manufacturing in a modern pharmaceutical manufacturing environment
  • Significant experience in a senior Quality role- a Quality Leader.
Key Information
  • Hybrid work model- 1 or 2 days WFH a week
  • Formal training and development programme will be provided specific to the role, which enables succession planning and a long term career path
  • Company pension
  • Competitive salary and bonus
  • Health benefits- private medical insurance for you and your partner, life assurance, critical illness insurance and income protection
  • Flexible benefits via salary sacrifice
  • Cycle to work scheme
  • Online and in store discounts
Please apply with you CV and you will be called to discuss your expertise and the role in more detail.
01273 952176 katie.dunbar@rbwconsulting.com