Job Reference: J5632236
Updated On: 20/09/2019
Status: Under Offer
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Role OverviewWe are currently looking for a Qualified Person (QP) to join a Pharmaceutical company based in the Essex region. As the Qualified Person, you will be responsible for developing site wide Quality systems with the Quality Director, alongside batch release duties.
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 heavily involved with the design and implementation of Quality Systems, working with the Head Office as well as distribution sites. You will be tasked with ensuring that the sites are inspection-ready in accordance with all aspects of GxP.
2. You will provide support for all aspects of GxP compliance, including Auditing, Gap Analysis, Validation and will provide training to staff on aspects associated with these.
3. As the Qualified Person, you will be working with internal and external customers, and will provide support with regulatory inspections, utilising your knowledge and expertise.
4. You will participate with batch release and recall procedures as well as provide support with customer complaints.
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. QP qualification is essential although previous releasing experience is not.
2. Quality Assurance and QMS development within a pharmaceutical or life science field.
3. Prior auditing experience is required.
Key Words: Qualified Person | QP | Batch Release | Quality Assurance | QA | Quality Manager | Quality Systems | Audit | GxP | Regulatory | MHRA | International | Validation | QMS
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