Job Title: Quality Assurance Associate
Job Type: Full-time, Permanent
Location: Codford, Wiltshire, UK – On-site
Cpl Life Sciences is collaborating with a growing organisation that meets patient demand for a dependable supply of high quality, UK produced, cannabis-based medicines. The business operates a brand-new state of the art growing facility, processing environment, and laboratory.
Primary responsibilities:
* Ensuring the maintenance and inspection readiness of our GMP quality management system
* Managing Quality Events such as deviations, CAPAs, and change controls
* Managing the GACP QMS
* Assisting with Home Office licensing compliance where required.
* Writing, updating and reviewing records, SOPs, and other documents
* Working with the Production Manager and the Quality Control Manager to ensure compliance with the QMS and Good Documentation Practice
* Track and ensure compliance with SOP review cycles and training
Quality Event Management:
* Identifying and raising deviations
* Leading root cause analysis
* Generating and implementing CAPA plans
* Change management and post-implementation review
* Tracking QE metrics and reporting them to the business
Self-inspection
* Oversee self-inspections of the quality system and conduct independent audits and risk assessments for all relevant activities
* Maintain knowledge and understanding of regulatory requirements in relation to the role
Supplier Management
* Oversee the approval of Customers and Suppliers
* Where required, communicate and work with the external supplier's QA functions
Communication:
* Working closely and communicating effectively with the Growing, Production, Quality Control and Commercial functions to ensure the product is released safely and efficiently
Controlled Drugs
* Assisting with Home Office licensing compliance where required
Desired Qualifications and Experience:
* Experience in a GxP environment
* Management of a QMS and quality events
* Relevant degree
For more information, please contact lucy.kirkaldy@cpl.com
This role is working for a startup organisation, so you must be a strong communicator who is dynamic and able to pick up things quickly. Due to the nature of the work, this will be 100% on site, and you must own your own car to travel to the site.
The working hours are 8am till 5pm and it a 42hr week.