Role Title: 2x Process Quality Specialist
Location: Remote in the UK or Hybrid in Uxbridge
FTE: 37.5 hours/week
Contract Length: 12 Months with an high chance of extension/going permanent
Company Summary
Our client is a global biopharmaceutical company, specializing in the discovery and development of innovative medicines and solutions for severe diseases such as neurology and immunology. Our client operates in over 40 countries, with a diverse workforce and global reach. Joining this company means becoming part of a dynamic and forward-thinking organization committed to making a difference in healthcare. With its strong emphasis on innovation, collaboration, and patient impact, Our client offers a fulfilling career for those passionate about creating solutions that improve lives globally.
Role Summary
In this role you will work in collaboration with Clinical Development Quality, Patient Safety, Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness. In addition, you will act as the audit and inspection contact for internal/external PV and Clinical audits and be the document owner for the relevant audit and inspection guidance documents. Following any findings you would work with the relevant stakeholder on any responses and subsequent CAPAs and where necessary create new processes to fill any identified gaps etc.
Required experience
* Minimum 4 years of experience in a GCP Quality Role
* Experience with GCP audits & Inspections experience
* Gap analysis experience & Experience writing SOPs
If you would like to discuss this vacancy further or to discuss your career options in confidence, please email me on: folubodun@planet-pharma.co.uk
If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.