A suitable Qualified Person will have extensive QP experience, working in an FDA environment.
Key Result Areas and Primary Activities
- Completes audits to ensure compliance to SOPs, GMPs and applicable regulations.
- Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review and QP certification.
- Manage product recalls and stock recoveries as appropriate.
- Identify compliance gaps, make and facilitate implementing recommendations for continuous improvement.
- Creates and maintains assigned SOPs.
- Perform and review complaints and deviation investigations, change controls and CAPA’s.
- Compiles data for reports and presentations, provides data interpretation draws conclusions.
- Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and
- Independent development, documentation and maintenance of business process and solutions.
We are looking to bring in a contract Qualfied Person/QP to help follow on from a recent FDA inspection so do not hesitate in submitting your profile!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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