A Day in the Life of our R&D Quality Manager
To develop, maintain, implement and improve quality standards and systems which give assurance that products comply with clinical dossiers, specifications and cGMP’s.
Ensuring that the quality system requirements are effectively established and efficiently maintained in accordance with the regulations.
To review and approve batch documentation, investigation reports, change requests, SOP’s, qualification reports, ensuring that they are completed right first time and in full accordance with Good Manufacturing Practice requirements
Responsible to support clinical trial batch releases / new product submissions / launches.
To carry out audits to ensure that all operational processes are in compliance with the required standards conforming to Company GMP, GLP, SOP’s, Specifications, Clinical/Submission dossier and audits vendors/suppliers/CMO’s as required.
Potential for this role to develop in a number of ways across the business
This role does not involve direct people management but has the capacity for the interested candidate to expand in that direction
Who we are looking for…..
Are you….
Educated to Degree or Masters Level in a science subject.
Do you have?
3-5 Years experience in Quality Assurance/Quality Auditing
Experience in regulatory requirements with respect with either Pharmaceutical or Combination Products
Qualified Person status/eligibility is preferable but not essential. Candidates looking to work towards QP status are also encouraged
Knowledge of cGMP, GLP, Regulatory Bodies and Customer requirements
Planning & organisational skills
Experienced decision maker
Strong communication and collaboration skills
