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GMP Trainer - Aseptic Manufacture

GMP Trainer - Aseptic Manufacture

Job Title: GMP Trainer - Aseptic Manufacture
Contract Type: Permanent
Location: Stevenage
Industry:
Salary: £35000 - £42000 per annum, Benefits: bonus, pension, life insurance, health insurance, 28 days holiday
Start Date: 2020-03-25
Reference: V-46139
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: March 25, 2020 18:39

Job Description

A cutting-edge biotech is recruiting for a GMP Trainer for their Stevenage site to take ownership of their training programmes by developing, implementing and then running these to support aseptic manufacturing.  This site operates on a multi occupancy basis where cell & gene therapies are manufactured for use in clinical trials to GMP.  In this role you will be working alongside the GMP Training Manager to deliver programmes for both collaborators and employees.  This is an influential role that includes responsibility for developing the training strategy as well as the hands-on training aspect.

As the GMP Trainer you will be working with the Training Manager to develop bespoke training programmes to be delivered to both employees and collaborators.  Alongside the day to day training you will also be working to develop and maintain their training strategy to keep pace with regulations and ensure training is sector leading. 

The training programmes cover all levels of employees at the site and you will be working with HR and Quality in this role.  You will be responsible for the delivery of training programmes for aseptic operations such as cleanroom use and gowning etc.  This also covers induction programmes for new starters along with refresher courses.  As this role is closely linked with Quality you will be supporting process training for deviation reporting, root cause analysis, and change management for example.  Additional responsibilities include participating in root cause and deviation trending events to then develop training to prevent further errors to increase right first time.

This is an influential role where you will be exposed to a range of business functions with input into key strategic areas so that GMP compliance is maintained at this unique cutting edge manufacturing centre.

Desired Skills and Experience:  You will need to have demonstrable experience of delivering training programmes in line with GMP in relevant aseptic manufacturing environments.  With experience that includes gowning, cleaning & disinfection activities inline with EuradraLex Vol 4, Annex 1.   With experience of writing, updating and improving written procedures for GMP manufacturing operations.  With hands on experience of deviations, change controls, and corrective actions being advantageous to your application. 

The Company:

The company are a leading the way in the commercialisation of life changing therapies, taking these through the commercialisation process using their expertise and cutting-edge services.   They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise to ensure these life changing therapies reach patients.  They are headquartered in Central London where their R&D laboratories are which are complemented by their multi occupancy GMP manufacturing facility based in Stevenage.  As a company they are driving this sector forwards looking for new innovations to adopt and sharing their expertise, so the sector reaches its full potential.