Job Reference: J5633083
Updated On: 09/03/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Qualified Person to join a leading Biopharmaceutical company based in the South East. As the Qualified Person you will be responsible for ensuring GMP compliance throughout the site, whilst also being tasked with batch release duties as specified in EU Directive 2001/83/EC and 2001/82/EC.
Key Duties and ResponsibilitiesYour duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
1. You will be named as the Qualified Person on the MIA and will ensure that all products are manufactured and released in accordance with EU directive 2001/83/EC.
2. As the Qualified Person, you will be responsible for ensuring the site wide compliance against regulatory standards such as GMP. You will have full over site of the companies Quality Systems, QMS, and will manage CAPAs, Deviations, Change Controls etc.
3. As a Qualified Person, you will also work closely with the wider Quality Assurance function, providing support where applicable.
Role RequirementsTo be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:
1. You will be recognised as a Qualified Person. The company offer a training and support function for their QP's and as such, no specific product release experience is necessary.
2. Experience managing a Quality System within a pharmaceutical or life science business to regulatory standards.
3. Any experience developing a Quality First Culture would be desirable.
Key Words: Qualified Person | QP | Quality Assurance | Quality Manager | GMP | QP | Aseptic | MHRA | QMS | Sterile | MIA | Release | Batch
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