1 month ago
Stoke Stoke-on-Trent Competitive Permanent
This is an outstanding career development opportunity for an individual looking to develop a career within validation. Working in exclusive partnership with one of our longest standing clients, we are supporting the evolution of this team as the site continues to advance its work within the advanced therapy manufacturing sector.
Given the growth on site, there is a very realistic scope for development and progression for an individual who wants to gain direct validation experience across process, equipment and CSV.
Working with the Validation Leader to manage the Validation system
Oversee and manage delivery of validation to GMP standards
Generation and review of validation documents
Carrying out equipment validation in a GMP cleanroom area
Routine qualifications of a variety of cleanroom/laboratory equipment
Direct involvement with the advancement of CSV implementation
Qualifications and experience
Degree level qualification in scientific subject
At least 12 months experience in a GMP quality, production or validation setting
An understanding and hands on experience of working in a cleanroom environment
An understanding of Deviations, CAPAs and change control processes with a willingness to develop these skills further
Experience and/or knowledge of some of the following equipment would be strong beneficial – bioreactors, chromatography, filter housing, incubators, freezers, autoclaves.
Some validation exposure or understanding would be a benefit but can be trained
Excellent communication and written/ verbal language
QA, quality assurance, officer, administrator, auditor, QC, MHRA, FDA, notified bodies, GMP, GLP, healthcare, biotechnology, pharmaceutical, biopharma, CSV, validation, validate, training, development, upstream, downstream, DSP, USP, fermentation, bioreactor, AKTA, chromatography, qualification, cleaning, equipment, process, installation.
Harris Lord is acting as a recruitment agency for this role